Directed fluidics

ABSTRACT

Methods and systems for administering directed fluidics during a medical procedure for removing an object are disclosed. A method includes inserting first and second medical instruments into a treatment site, providing irrigation and aspiration of the treatment site through the first and second medical instruments, determining a characteristic of one of the irrigation and the aspiration, and selecting a characteristic of the other of the irrigation and aspiration based on the determined characteristic.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATION(S)

This application is a continuation of U.S. application Ser. No.16/212,199, filed Dec. 6, 2018, which claims priority to U.S.Provisional Application No. 62/596,711, filed Dec. 8, 2017, each ofwhich is incorporated herein by reference. Any and all applications forwhich a foreign or domestic priority claim is identified in theApplication Data Sheet as filed with the present application are herebyincorporated by reference under 37 CFR 1.57.

TECHNICAL FIELD

The systems and methods disclosed herein are directed to medicalrobotics, and more particularly, to robotic medical systems and methodsemploying directed fluidics during procedures for removal of an objectfrom a patient.

BACKGROUND

Every year, physicians perform procedures to remove urinary stones frompatients' urinary tracts. Urinary stones may include kidney stones,found in the kidneys and ureters, as well as bladder stones, found inthe bladder. Such urinary stones may form as a result of concentratedminerals and may cause significant abdominal pain once they reach a sizesufficient to impede urine flow through the ureter or urethra. Suchstones may be formed from calcium, magnesium, ammonia, uric acid,cysteine, or other compounds.

To remove urinary stones from the bladder and ureter, physiciansgenerally use a ureteroscope inserted into the urinary tract through theurethra. Typically, a ureteroscope includes a scope at its distal end toenable visualization of the urinary tract. The procedure may alsoutilize a lithotomy mechanism to capture or break apart the urinarystones. During the ureteroscopy procedure, one physician may control theposition of the ureteroscope and the other physician may control thelithotomy mechanism. To remove large kidney stones from the kidneys,physicians generally use a percutaneous nephrolithotomy (PCNL) techniquethat includes inserting a nephroscope through the skin to break up andremove the kidney stones.

SUMMARY

This disclosure relates to systems and techniques for removing an objectfrom a treatment site of a patient, and in particular to methods andsystems that employ directed fluidics during an object removalprocedure. “Directed fluidics” can refer to methods and systems forproviding irrigation and aspiration (e.g., inflow and outflow of fluid)that improve or facilitate an object removal procedure. Directedfluidics can include setting, controlling, or adjusting characteristicsof irrigation and/or aspiration to achieve advantageous, beneficial, ordesirable fluid flows through a treatment site.

In a first aspect, a method of administering fluidics during a medicalprocedure, includes: inserting a first medical instrument into atreatment site, the first medical instrument comprising a first fluidchannel and a second fluid channel; providing irrigation into thetreatment site through the first fluid channel of the first medicalinstrument; providing aspiration from the treatment site through thesecond fluid channel of the first medical instrument; determining acharacteristic of one of the irrigation and the aspiration; andselecting a characteristic of the other of the irrigation and aspirationbased on the determined characteristic.

The method can include one or more of the following features, in anycombination: (a) wherein inserting the first medical instrument into thetreatment site comprises advancing the first medical instrumentpercutaneously into the treatment site; (b) wherein inserting the firstmedical instrument into the treatment site comprises advancing the firstmedical instrument through a lumen of a patient into the treatment site;(c) inserting a second medical instrument into the treatment sitethrough a lumen of the patient; (d) percutaneously inserting a secondmedical instrument into the treatment site; (e) wherein the determinedcharacteristic comprises at least one of an instantaneous flow rate andan average flow rate over a period of time; (f) wherein the selectedcharacteristic comprises at least one of an instantaneous flow rate andan average flow rate over a period of time; (g) wherein the selectedcharacteristic substantially matches the determined characteristic; (h)determining a characteristic of the treatment site, and when thedetermined characteristic of the treatment site exceeds a thresholdvalue, at least one of: reducing irrigation into the treatment site,increasing aspiration from the treatment site, and providing an alert;(i) wherein the determined characteristic of the treatment sitecomprises one of a volume of fluid within the treatment site and aninternal pressure of the treatment site; (j) moving a distal tip of thefirst medical instrument in a sweeping motion while providing irrigationor aspiration; (k) wherein at least one of the first medical instrumentand the second medical instrument is robotically controlled; (l)performing lithotripsy on an object within the treatment site to breakthe object into fragments, and aspirating the fragments through thesecond fluid channel of the first medical instrument; (m) whereinlithotripsy is performed with a second medical instrument; (n) whereinthe first medical instrument comprises a steerable medical instrumentcomprising an articulable distal end; (o) contacting an articulabledistal end of the first medical instrument to an object within thetreatment site, and providing aspiration through the second fluidchannel to hold the object to the articulable distal end; (p) whereinthe articulable distal end comprises a pocket configured to hold theobject; (q) performing lithotripsy while the object is held in thepocket; (r) moving the first medical instrument to reposition the objectwithin the treatment site; (s) performing lithotripsy on an objectwithin the treatment site to break the object into fragments, andaspirating, during the lithotripsy, through the second fluid channel toremove dust created by the lithotripsy; (t) wherein the additional firstfluid channel includes a fluid orifice that directs fluid away from thesecond medical instrument; (u) wherein irrigation and aspiration areprovided at the same time; and/or (v) wherein irrigation and aspirationare not provided at the same time.

In another aspect, a system for performing a medical procedure caninclude: a first medical instrument configured to be inserted into atreatment site, the first instrument including a first fluid channel anda second fluid channel; a vacuum connected to one of the first fluidchannel and the second fluid channel and configured to apply a negativepressure to provide aspiration from the treatment site; a pump coupledto an irrigation source and the other of the first fluid channel and thesecond fluid channel, the pump configured to provide irrigation to thetreatment site; and a fluidics control system coupled to the vacuum andthe pump, the fluidics control system comprising one or more processorsconfigured to: determine a characteristic of one of the irrigation andthe aspiration, and control a characteristic of at least one of the pumpor the vacuum based on the determined characteristic.

The system can include one or more of the following features in anycombination: (a) wherein the first medical instrument is configured tobe inserted through a lumen of a patient into the treatment site; (b)wherein the first medical instrument is configured to be insertedpercutaneously into the treatment site; (c) wherein further comprising asecond medical instrument is configured to be inserted through a lumenof a patient into the treatment site; (d) comprising a second medicalinstrument that is configured to be inserted percutaneously into thetreatment site; (e) wherein the first medical instrument furthercomprises a flow rate sensor positioned in the first fluid channel, andwherein an output of the flow rate sensor is connected to the fluidicscontrol system; (f) wherein the second first medical instrument furthercomprises a flow rate sensor positioned in the second fluid channel, andwherein an output of the flow rate sensor is connected to the fluidicscontrol system; (g) wherein the first medical instrument furthercomprises a pressure sensor disposed to measure an internal pressure ofthe treatment site, an output of the pressure sensor connected to thefluidics control system, and wherein the one or more processors arefurther configured to control at least one of the pump or the vacuum toadjust at least one of the aspiration and the irrigation based on themeasured internal pressure of the treatment site; (h) a second medicalinstrument configured to be inserted into the treatment site, whereinthe second medical instrument further comprises a pressure sensordisposed to measure an internal pressure of the treatment site, anoutput of the pressure sensor connected to the fluidics control system,and wherein the one or more processors are further configured to controlat least one of the pump or the vacuum to adjust at least one of theaspiration and irrigation based on the measured internal pressure of thetreatment site; and/or (i) wherein the first medical instrumentcomprises an articulable distal end.

In another aspect, a medical device can include: an articulable elongatebody extending along an axis to a distal end; a first fluid channelextending along the axis, the first fluid channel terminating in a firstfluid orifice formed in a distal face of the distal end; and at leastone additional fluid channel formed through the elongate body, the atleast one additional fluid channel terminating in at least oneadditional fluid exit orifice formed in a radial surface of the elongatebody proximal the distal end.

The medical device can include one or more of the following features inany combination: (a) a pocket formed in the distal face; (b) wherein thepocket is configured to at least partially receive an object to beremoved during a medical procedure; (c) wherein the at least oneadditional channel annularly surrounds the first fluid channel; (d)wherein the at least one additional fluid orifice comprises additionalfluid orifices positioned around the axis; (e) wherein the at least oneadditional channel comprises additional channels positioned radiallyaround the first fluid channel; (f) wherein each of the four additionalfluid channels terminates at an additional fluid orifice positionedradially around the axis; and/or (g) at least one pull wire forarticulating the elongate body.

In another aspect, a non-transitory computer readable storage medium caninclude stored thereon instructions that, when executed, cause aprocessor of a device to at least: determine a characteristic of atleast one of irrigation into a treatment site through a first channel ofa first medical instrument and an aspiration from the treatment sitethrough a second channel of the first medical instrument; and select acharacteristic of at least one of the irrigation and the aspirationbased on the determined characteristic.

The non-transitory computer readable storage medium can include one ormore of the following features in any combination: (a) wherein thedetermined characteristic comprises at least one of an instantaneousflow rate and an average flow rate over a period of time; (b) whereinthe selected characteristic comprises at least one of an instantaneousflow rate and an average flow rate over a period of time; (c) whereinthe selected characteristic substantially matches the determinedcharacteristic; (d) wherein the instructions, when executed furthercause the processor to determine a characteristic of the treatment site,and when the determined characteristic of the treatment site exceeds athreshold value, at least one of: reduce irrigation into the treatmentsite, increase aspiration from the treatment site, and provide an alert;(e) wherein the determined characteristic of the treatment sitecomprises one of a volume of fluid within the treatment site and aninternal pressure of the treatment site; (f) wherein the instructions,when executed further cause the processor to: perform lithotripsy with asecond medical instrument on an object within the treatment site tobreak the object into fragments, and aspirate the fragments through thesecond fluid channel of the second first medical instrument; (g) whereinthe instructions, when executed further cause the processor to: performlithotripsy with a second medical instrument on an object within thetreatment site to break the object into fragments, and aspirate, duringthe lithotripsy, through the second fluid channel of the second firstmedical instrument to remove dust created by the lithotripsy; (h)wherein the instructions, when executed further cause the processor toprovide irrigation and aspiration at the same time; and/or (i) whereinirrigation and aspiration are not provided at the same time.

In another aspect, a method of administering fluidics during the removalof an object from a patient can include: advancing a first medicalinstrument through a lumen of a patient toward a treatment sitecontaining an object to be removed, the first medical instrumentcomprising a first fluid channel for providing irrigation through afirst aperture positioned on a remotely articulable distal tip, thefirst aperture configured to provide irrigation in a first fluid flowdirection; inserting a second medical instrument percutaneously into thetreatment site, the second medical instrument comprising a second fluidchannel for providing aspiration through a second aperture of the secondfluid channel; providing irrigation into the treatment site with thefirst medical instrument through the first aperture; providingaspiration from the treatment site through the second aperture of thesecond fluid channel of the second medical instrument; and remotelymanipulating the distal tip of the first medical instrument such thatthe first fluid direction is oriented towards the second aperture.

The method can include one or more of the following features in anycombination: (a) determining the position of the second aperture withinthe treatment site, and wherein manipulating the distal tip comprisesautomatically manipulating the distal tip based on the determinedposition of the second aperture within the treatment site; (b) wherein anephroscope comprises the second medical instrument and a lithotripter,and wherein the method further comprises: contacting the lithotripter tothe object, performing lithotripsy to break the object into fragments,and aspirating the fragments with the suction tube; and/or (c) moving adistal tip of the first medical instrument in a sweeping motion whileproviding irrigation through the first medical instrument.

Although this disclosure is largely described with respect to exampleuse cases of ureteroscopy, percutaneous nephrolithotomy (PCNL), and theremoval of urinary stones and stone fragments, this disclosure may beequally applicable to other surgical/medical operations concerned withthe removal of objects from various treatment sites of the patient,including any object that can be safely removed via a patient cavity(e.g., the esophagus, ureter, intestine, etc.) or via percutaneousaccess, such as gallbladder stone removal or lung(pulmonary/transthoracic) tumor biopsy.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIG. 1 illustrates an embodiment of a cart-based robotic system arrangedfor diagnostic and/or therapeutic bronchoscopy procedure(s).

FIG. 2 depicts further aspects of the robotic system of FIG. 1.

FIG. 3 illustrates an embodiment of the robotic system of FIG. 1arranged for ureteroscopy.

FIG. 4 illustrates an embodiment of the robotic system of FIG. 1arranged for a vascular procedure.

FIG. 5 illustrates an embodiment of a table-based robotic systemarranged for a bronchoscopy procedure.

FIG. 6 provides an alternative view of the robotic system of FIG. 5.

FIG. 7 illustrates an example system configured to stow robotic arm(s).

FIG. 8 illustrates an embodiment of a table-based robotic systemconfigured for a ureteroscopy procedure.

FIG. 9 illustrates an embodiment of a table-based robotic systemconfigured for a laparoscopic procedure.

FIG. 10 illustrates an embodiment of the table-based robotic system ofFIGS. 5-9 with pitch or tilt adjustment.

FIG. 11 provides a detailed illustration of the interface between thetable and the column of the table-based robotic system of FIGS. 5-10.

FIG. 12 illustrates an exemplary instrument driver.

FIG. 13 illustrates an exemplary medical instrument with a pairedinstrument driver.

FIG. 14 illustrates an alternative design for an instrument driver andinstrument where the axes of the drive units are parallel to the axis ofthe elongated shaft of the instrument.

FIG. 15 depicts a block diagram illustrating a localization system thatestimates a location of one or more elements of the robotic systems ofFIGS. 1-10, such as the location of the instrument of FIGS. 13 and 14,in accordance to an example embodiment.

FIG. 16 illustrates an example procedure for removing an object from akidney using a first medical instrument inserted into the kidneypercutaneously.

FIG. 17 illustrates an example procedure for removing an object from akidney using a first medical instrument inserted into the kidney througha patient lumen, a second medical instrument inserted into the kidneypercutaneously, and directed fluidics.

FIG. 18 illustrates another example procedure for removing an objectfrom a kidney using a first medical instrument inserted into the kidneythrough a patient lumen, a second medical instrument inserted into thekidney percutaneously, and directed fluidics.

FIG. 19 illustrates another example procedure for removing an objectfrom a kidney using a first medical instrument inserted into the kidneythrough a patient lumen, a second medical instrument inserted into thekidney percutaneously, and directed fluidics.

FIG. 20 illustrates a detailed view of a distal tip of a first medicalinstrument providing irrigation and a distal tip of a second medicalinstrument providing aspiration during an object removal procedure.

FIG. 21A illustrates a detailed view of a distal tip of a first medicalinstrument providing irrigation and a distal tip of a second medicalinstrument providing irrigation and aspiration during an object removalprocedure.

FIG. 21B illustrates a detailed view of a distal tip of a first medicalinstrument performing lithotomy and a distal tip of a second medicalinstrument providing irrigation and aspiration during an object removalprocedure.

FIG. 22A is a flowchart illustrating an embodiment of a method fordirected fluidics during an object removal procedure.

FIG. 22B is a flowchart illustrating an embodiment of another method fordirected fluidics during an object removal procedure.

FIG. 23 is a flowchart illustrating an embodiment of another method fordirected fluidics during an object removal procedure.

FIG. 24 is a flowchart illustrating an embodiment of a method forholding and repositioning an object using directed fluidics during anobject removal procedure.

FIG. 25 is a block diagram illustrating an embodiment of a system fordirected fluidics.

FIG. 26A is a perspective view of a distal end of a medical instrumentconfigured to provide aspiration and irrigation during an object removalprocedure.

FIG. 26B is a cross-sectional view of the distal end of the medicalinstrument of FIG. 26A, illustrating the irrigation and aspirationchannels within the medical instrument.

FIG. 27 illustrates an embodiment of a robotic system arranged forperforming an object removal procedure using directed fluidics.

DETAILED DESCRIPTION 1. Overview.

Aspects of the present disclosure may be integrated into arobotically-enabled medical system capable of performing a variety ofmedical procedures, including both minimally invasive, such aslaparoscopy, and non-invasive, such as endoscopy, procedures. Amongendoscopy procedures, the system may be capable of performingbronchoscopy, ureteroscopy, gastroscopy, etc.

In addition to performing the breadth of procedures, the system mayprovide additional benefits, such as enhanced imaging and guidance toassist the physician. Additionally, the system may provide the physicianwith the ability to perform the procedure from an ergonomic positionwithout the need for awkward arm motions and positions. Still further,the system may provide the physician with the ability to perform theprocedure with improved ease of use such that one or more of theinstruments of the system can be controlled by a single user.

Various embodiments will be described below in conjunction with thedrawings for purposes of illustration. It should be appreciated thatmany other implementations of the disclosed concepts are possible, andvarious advantages can be achieved with the disclosed implementations.Headings are included herein for reference and to aid in locatingvarious sections. These headings are not intended to limit the scope ofthe concepts described with respect thereto. Such concepts may haveapplicability throughout the entire specification.

A. Robotic System—Cart.

The robotically-enabled medical system may be configured in a variety ofways depending on the particular procedure. FIG. 1 illustrates anembodiment of a cart-based robotically-enabled system 10 arranged for adiagnostic and/or therapeutic bronchoscopy procedure. During abronchoscopy, the system 10 may comprise a cart 11 having one or morerobotic arms 12 to deliver a medical instrument, such as a steerableendoscope 13, which may be a procedure-specific bronchoscope forbronchoscopy, to a natural orifice access point (i.e., the mouth of thepatient positioned on a table in the present example) to deliverdiagnostic and/or therapeutic tools. As shown, the cart 11 may bepositioned proximate to the patient's upper torso in order to provideaccess to the access point. Similarly, the robotic arms 12 may beactuated to position the bronchoscope relative to the access point. Thearrangement in FIG. 1 may also be utilized when performing agastro-intestinal (GI) procedure with a gastroscope, a specializedendoscope for GI procedures. FIG. 2 depicts an example embodiment of thecart in greater detail.

With continued reference to FIG. 1, once the cart 11 is properlypositioned, the robotic arms 12 may insert the steerable endoscope 13into the patient robotically, manually, or a combination thereof. Asshown, the steerable endoscope 13 may comprise at least two telescopingparts, such as an inner leader portion and an outer sheath portion, eachportion coupled to a separate instrument driver from the set ofinstrument drivers 28, each instrument driver coupled to the distal endof an individual robotic arm. This linear arrangement of the instrumentdrivers 28, which facilitates coaxially aligning the leader portion withthe sheath portion, creates a “virtual rail” 29 that may be repositionedin space by manipulating the one or more robotic arms 12 into differentangles and/or positions. The virtual rails described herein are depictedin the Figures using dashed lines, and accordingly the dashed lines donot depict any physical structure of the system. Translation of theinstrument drivers 28 along the virtual rail 29 telescopes the innerleader portion relative to the outer sheath portion or advances orretracts the endoscope 13 from the patient. The angle of the virtualrail 29 may be adjusted, translated, and pivoted based on clinicalapplication or physician preference. For example, in bronchoscopy, theangle and position of the virtual rail 29 as shown represents acompromise between providing physician access to the endoscope 13 whileminimizing friction that results from bending the endoscope 13 into thepatient's mouth.

The endoscope 13 may be directed down the patient's trachea and lungsafter insertion using precise commands from the robotic system untilreaching the target destination or operative site. In order to enhancenavigation through the patient's lung network and/or reach the desiredtarget, the endoscope 13 may be manipulated to telescopically extend theinner leader portion from the outer sheath portion to obtain enhancedarticulation and greater bend radius. The use of separate instrumentdrivers 28 also allows the leader portion and sheath portion to bedriven independent of each other.

For example, the endoscope 13 may be directed to deliver a biopsy needleto a target, such as, for example, a lesion or nodule within the lungsof a patient. The needle may be deployed down a working channel thatruns the length of the endoscope to obtain a tissue sample to beanalyzed by a pathologist. Depending on the pathology results,additional tools may be deployed down the working channel of theendoscope for additional biopsies. After identifying a nodule to bemalignant, the endoscope 13 may endoscopically deliver tools to resectthe potentially cancerous tissue. In some instances, diagnostic andtherapeutic treatments may need to be delivered in separate procedures.In those circumstances, the endoscope 13 may also be used to deliver afiducial to “mark” the location of the target nodule as well. In otherinstances, diagnostic and therapeutic treatments may be delivered duringthe same procedure.

The system 10 may also include a movable tower 30, which may beconnected via support cables to the cart 11 to provide support forcontrols, electronics, fluidics, optics, sensors, and/or power to thecart 11. Placing such functionality in the tower 30 allows for a smallerform factor cart 11 that may be more easily adjusted and/or repositionedby an operating physician and his/her staff. Additionally, the divisionof functionality between the cart/table and the support tower 30 reducesoperating room clutter and facilitates improving clinical workflow.While the cart 11 may be positioned close to the patient, the tower 30may be stowed in a remote location to stay out of the way during aprocedure.

In support of the robotic systems described above, the tower 30 mayinclude component(s) of a computer-based control system that storescomputer program instructions, for example, within a non-transitorycomputer-readable storage medium such as a persistent magnetic storagedrive, solid state drive, etc. The execution of those instructions,whether the execution occurs in the tower 30 or the cart 11, may controlthe entire system or sub-system(s) thereof. For example, when executedby a processor of the computer system, the instructions may cause thecomponents of the robotics system to actuate the relevant carriages andarm mounts, actuate the robotics arms, and control the medicalinstruments. For example, in response to receiving the control signal,the motors in the joints of the robotics arms may position the arms intoa certain posture.

The tower 30 may also include a pump, flow meter, valve control, and/orfluid access in order to provide controlled irrigation and aspirationcapabilities to system that may be deployed through the endoscope 13.These components may also be controlled using the computer system oftower 30. In some embodiments, irrigation and aspiration capabilitiesmay be delivered directly to the endoscope 13 through separate cable(s).

The tower 30 may include a voltage and surge protector designed toprovide filtered and protected electrical power to the cart 11, therebyavoiding placement of a power transformer and other auxiliary powercomponents in the cart 11, resulting in a smaller, more moveable cart11.

The tower 30 may also include support equipment for the sensors deployedthroughout the robotic system 10. For example, the tower 30 may includeopto-electronics equipment for detecting, receiving, and processing datareceived from the optical sensors or cameras throughout the roboticsystem 10. In combination with the control system, such opto-electronicsequipment may be used to generate real-time images for display in anynumber of consoles deployed throughout the system, including in thetower 30. Similarly, the tower 30 may also include an electronicsubsystem for receiving and processing signals received from deployedelectromagnetic (EM) sensors. The tower 30 may also be used to house andposition an EM field generator for detection by EM sensors in or on themedical instrument.

The tower 30 may also include a console 31 in addition to other consolesavailable in the rest of the system, e.g., console mounted on top of thecart. The console 31 may include a user interface and a display screen,such as a touchscreen, for the physician operator. Consoles in system 10are generally designed to provide both robotic controls as well aspre-operative and real-time information of the procedure, such asnavigational and localization information of the endoscope 13. When theconsole 31 is not the only console available to the physician, it may beused by a second operator, such as a nurse, to monitor the health orvitals of the patient and the operation of system, as well as provideprocedure-specific data, such as navigational and localizationinformation.

The tower 30 may be coupled to the cart 11 and endoscope 13 through oneor more cables or connections (not shown). In some embodiments, thesupport functionality from the tower 30 may be provided through a singlecable to the cart 11, simplifying and de-cluttering the operating room.In other embodiments, specific functionality may be coupled in separatecabling and connections. For example, while power may be providedthrough a single power cable to the cart, the support for controls,optics, fluidics, and/or navigation may be provided through a separatecable.

FIG. 2 provides a detailed illustration of an embodiment of the cartfrom the cart-based robotically-enabled system shown in FIG. 1. The cart11 generally includes an elongated support structure 14 (often referredto as a “column”), a cart base 15, and a console 16 at the top of thecolumn 14. The column 14 may include one or more carriages, such as acarriage 17 (alternatively “arm support”) for supporting the deploymentof one or more robotic arms 12 (three shown in FIG. 2). The carriage 17may include individually configurable arm mounts that rotate along aperpendicular axis to adjust the base of the robotic arms 12 for betterpositioning relative to the patient. The carriage 17 also includes acarriage interface 19 that allows the carriage 17 to verticallytranslate along the column 14.

The carriage interface 19 is connected to the column 14 through slots,such as slot 20, that are positioned on opposite sides of the column 14to guide the vertical translation of the carriage 17. The slot 20contains a vertical translation interface to position and hold thecarriage at various vertical heights relative to the cart base 15.Vertical translation of the carriage 17 allows the cart 11 to adjust thereach of the robotic arms 12 to meet a variety of table heights, patientsizes, and physician preferences. Similarly, the individuallyconfigurable arm mounts on the carriage 17 allow the robotic arm base 21of robotic arms 12 to be angled in a variety of configurations.

In some embodiments, the slot 20 may be supplemented with slot coversthat are flush and parallel to the slot surface to prevent dirt andfluid ingress into the internal chambers of the column 14 and thevertical translation interface as the carriage 17 vertically translates.The slot covers may be deployed through pairs of spring spoolspositioned near the vertical top and bottom of the slot 20. The coversare coiled within the spools until deployed to extend and retract fromtheir coiled state as the carriage 17 vertically translates up and down.The spring-loading of the spools provides force to retract the coverinto a spool when carriage 17 translates towards the spool, while alsomaintaining a tight seal when the carriage 17 translates away from thespool. The covers may be connected to the carriage 17 using, forexample, brackets in the carriage interface 19 to ensure properextension and retraction of the cover as the carriage 17 translates.

The column 14 may internally comprise mechanisms, such as gears andmotors, that are designed to use a vertically aligned lead screw totranslate the carriage 17 in a mechanized fashion in response to controlsignals generated in response to user inputs, e.g., inputs from theconsole 16.

The robotic arms 12 may generally comprise robotic arm bases 21 and endeffectors 22, separated by a series of linkages 23 that are connected bya series of joints 24, each joint comprising an independent actuator,each actuator comprising an independently controllable motor. Eachindependently controllable joint represents an independent degree offreedom available to the robotic arm. Each of the arms 12 have sevenjoints, and thus provide seven degrees of freedom. A multitude of jointsresult in a multitude of degrees of freedom, allowing for “redundant”degrees of freedom. Redundant degrees of freedom allow the robotic arms12 to position their respective end effectors 22 at a specific position,orientation, and trajectory in space using different linkage positionsand joint angles. This allows for the system to position and direct amedical instrument from a desired point in space while allowing thephysician to move the arm joints into a clinically advantageous positionaway from the patient to create greater access, while avoiding armcollisions.

The cart base 15 balances the weight of the column 14, carriage 17, andarms 12 over the floor. Accordingly, the cart base 15 houses heaviercomponents, such as electronics, motors, power supply, as well ascomponents that either enable movement and/or immobilize the cart. Forexample, the cart base 15 includes rollable wheel-shaped casters 25 thatallow for the cart to easily move around the room prior to a procedure.After reaching the appropriate position, the casters 25 may beimmobilized using wheel locks to hold the cart 11 in place during theprocedure.

Positioned at the vertical end of column 14, the console 16 allows forboth a user interface for receiving user input and a display screen (ora dual-purpose device such as, for example, a touchscreen 26) to providethe physician user with both pre-operative and intra-operative data.Potential pre-operative data on the touchscreen 26 may includepre-operative plans, navigation and mapping data derived frompre-operative computerized tomography (CT) scans, and/or notes frompre-operative patient interviews. Intra-operative data on display mayinclude optical information provided from the tool, sensor andcoordinate information from sensors, as well as vital patientstatistics, such as respiration, heart rate, and/or pulse. The console16 may be positioned and tilted to allow a physician to access theconsole from the side of the column 14 opposite carriage 17. From thisposition, the physician may view the console 16, robotic arms 12, andpatient while operating the console 16 from behind the cart 11. Asshown, the console 16 also includes a handle 27 to assist withmaneuvering and stabilizing cart 11.

FIG. 3 illustrates an embodiment of a robotically-enabled system 10arranged for ureteroscopy. In a ureteroscopic procedure, the cart 11 maybe positioned to deliver a ureteroscope 32, a procedure-specificendoscope designed to traverse a patient's urethra and ureter, to thelower abdominal area of the patient. In ureteroscopy, it may bedesirable for the ureteroscope 32 to be directly aligned with thepatient's urethra to reduce friction and forces on the sensitive anatomyin the area. As shown, the cart 11 may be aligned at the foot of thetable to allow the robotic arms 12 to position the ureteroscope 32 fordirect linear access to the patient's urethra. From the foot of thetable, the robotic arms 12 may insert the ureteroscope 32 along thevirtual rail 33 directly into the patient's lower abdomen through theurethra.

After insertion into the urethra, using similar control techniques as inbronchoscopy, the ureteroscope 32 may be navigated into the bladder,ureters, and/or kidneys for diagnostic and/or therapeutic applications.For example, the ureteroscope 32 may be directed into the ureter andkidneys to break up kidney stone build up using laser or ultrasoniclithotripsy device deployed down the working channel of the ureteroscope32. After lithotripsy is complete, the resulting stone fragments may beremoved using baskets deployed down the ureteroscope 32.

FIG. 4 illustrates an embodiment of a robotically-enabled systemsimilarly arranged for a vascular procedure. In a vascular procedure,the system 10 may be configured such the cart 11 may deliver a medicalinstrument 34, such as a steerable catheter, to an access point in thefemoral artery in the patient's leg. The femoral artery presents both alarger diameter for navigation as well as relatively less circuitous andtortuous path to the patient's heart, which simplifies navigation. As ina ureteroscopic procedure, the cart 11 may be positioned towards thepatient's legs and lower abdomen to allow the robotic arms 12 to providea virtual rail 35 with direct linear access to the femoral artery accesspoint in the patient's thigh/hip region. After insertion into theartery, the medical instrument 34 may be directed and inserted bytranslating the instrument drivers 28. Alternatively, the cart may bepositioned around the patient's upper abdomen in order to reachalternative vascular access points, such as, for example, the carotidand brachial arteries near the shoulder and wrist.

B. Robotic System—Table.

Embodiments of the robotically-enabled medical system may alsoincorporate the patient's table. Incorporation of the table reduces theamount of capital equipment within the operating room by removing thecart, which allows greater access to the patient. FIG. 5 illustrates anembodiment of such a robotically-enabled system arranged for abronchoscopy procedure. System 36 includes a support structure or column37 for supporting platform 38 (shown as a “table” or “bed”) over thefloor. Much like in the cart-based systems, the end effectors of therobotic arms 39 of the system 36 comprise instrument drivers 42 that aredesigned to manipulate an elongated medical instrument, such as abronchoscope 40 in FIG. 5, through or along a virtual rail 41 formedfrom the linear alignment of the instrument drivers 42. In practice, aC-arm for providing fluoroscopic imaging may be positioned over thepatient's upper abdominal area by placing the emitter and detectoraround table 38.

FIG. 6 provides an alternative view of the system 36 without the patientand medical instrument for discussion purposes. As shown, the column 37may include one or more carriages 43 shown as ring-shaped in the system36, from which the one or more robotic arms 39 may be based. Thecarriages 43 may translate along a vertical column interface 44 thatruns the length of the column 37 to provide different vantage pointsfrom which the robotic arms 39 may be positioned to reach the patient.The carriage(s) 43 may rotate around the column 37 using a mechanicalmotor positioned within the column 37 to allow the robotic arms 39 tohave access to multiples sides of the table 38, such as, for example,both sides of the patient. In embodiments with multiple carriages, thecarriages may be individually positioned on the column and may translateand/or rotate independent of the other carriages. While carriages 43need not surround the column 37 or even be circular, the ring-shape asshown facilitates rotation of the carriages 43 around the column 37while maintaining structural balance. Rotation and translation of thecarriages 43 allows the system to align the medical instruments, such asendoscopes and laparoscopes, into different access points on thepatient.

The arms 39 may be mounted on the carriages through a set of arm mounts45 comprising a series of joints that may individually rotate and/ortelescopically extend to provide additional configurability to therobotic arms 39. Additionally, the arm mounts 45 may be positioned onthe carriages 43 such that, when the carriages 43 are appropriatelyrotated, the arm mounts 45 may be positioned on either the same side oftable 38 (as shown in FIG. 6), on opposite sides of table 38 (as shownin FIG. 9), or on adjacent sides of the table 38 (not shown).

The column 37 structurally provides support for the table 38, and a pathfor vertical translation of the carriages. Internally, the column 37 maybe equipped with lead screws for guiding vertical translation of thecarriages, and motors to mechanize the translation of said carriagesbased the lead screws. The column 37 may also convey power and controlsignals to the carriage 43 and robotic arms 39 mounted thereon.

The table base 46 serves a similar function as the cart base 15 in cart11 shown in FIG. 2, housing heavier components to balance the table/bed38, the column 37, the carriages 43, and the robotic arms 39. The tablebase 46 may also incorporate rigid casters to provide stability duringprocedures. Deployed from the bottom of the table base 46, the castersmay extend in opposite directions on both sides of the base 46 andretract when the system 36 needs to be moved.

Continuing with FIG. 6, the system 36 may also include a tower (notshown) that divides the functionality of system 36 between table andtower to reduce the form factor and bulk of the table. As in earlierdisclosed embodiments, the tower may provide a variety of supportfunctionalities to table, such as processing, computing, and controlcapabilities, power, fluidics, and/or optical and sensor processing. Thetower may also be movable to be positioned away from the patient toimprove physician access and de-clutter the operating room.Additionally, placing components in the tower allows for more storagespace in the table base for potential stowage of the robotic arms. Thetower may also include a console that provides both a user interface foruser input, such as keyboard and/or pendant, as well as a display screen(or touchscreen) for pre-operative and intra-operative information, suchas real-time imaging, navigation, and tracking information.

In some embodiments, a table base may stow and store the robotic armswhen not in use. FIG. 7 illustrates a system 47 that stows robotic armsin an embodiment of the table-based system. In system 47, carriages 48may be vertically translated into base 49 to stow robotic arms 50, armmounts 51, and the carriages 48 within the base 49. Base covers 52 maybe translated and retracted open to deploy the carriages 48, arm mounts51, and arms 50 around column 53, and closed to stow to protect themwhen not in use. The base covers 52 may be sealed with a membrane 54along the edges of its opening to prevent dirt and fluid ingress whenclosed.

FIG. 8 illustrates an embodiment of a robotically-enabled table-basedsystem configured for a ureteroscopy procedure. In ureteroscopy, thetable 38 may include a swivel portion 55 for positioning a patientoff-angle from the column 37 and table base 46. The swivel portion 55may rotate or pivot around a pivot point (e.g., located below thepatient's head) in order to position the bottom portion of the swivelportion 55 away from the column 37. For example, the pivoting of theswivel portion 55 allows a C-arm (not shown) to be positioned over thepatient's lower abdomen without competing for space with the column (notshown) below table 38. By rotating the carriage 35 (not shown) aroundthe column 37, the robotic arms 39 may directly insert a ureteroscope 56along a virtual rail 57 into the patient's groin area to reach theurethra. In ureteroscopy, stirrups 58 may also be fixed to the swivelportion 55 of the table 38 to support the position of the patient's legsduring the procedure and allow clear access to the patient's groin area.

In a laparoscopic procedure, through small incision(s) in the patient'sabdominal wall, minimally invasive instruments (elongated in shape toaccommodate the size of the one or more incisions) may be inserted intothe patient's anatomy. After inflation of the patient's abdominalcavity, the instruments, often referred to as laparoscopes, may bedirected to perform surgical tasks, such as grasping, cutting, ablating,suturing, etc. FIG. 9 illustrates an embodiment of a robotically-enabledtable-based system configured for a laparoscopic procedure. As shown inFIG. 9, the carriages 43 of the system 36 may be rotated and verticallyadjusted to position pairs of the robotic arms 39 on opposite sides ofthe table 38, such that laparoscopes 59 may be positioned using the armmounts 45 to be passed through minimal incisions on both sides of thepatient to reach his/her abdominal cavity.

To accommodate laparoscopic procedures, the robotically-enabled tablesystem may also tilt the platform to a desired angle. FIG. 10illustrates an embodiment of the robotically-enabled medical system withpitch or tilt adjustment. As shown in FIG. 10, the system 36 mayaccommodate tilt of the table 38 to position one portion of the table ata greater distance from the floor than the other. Additionally, the armmounts 45 may rotate to match the tilt such that the arms 39 maintainthe same planar relationship with table 38. To accommodate steeperangles, the column 37 may also include telescoping portions 60 thatallow vertical extension of column 37 to keep the table 38 from touchingthe floor or colliding with base 46.

FIG. 11 provides a detailed illustration of the interface between thetable 38 and the column 37. Pitch rotation mechanism 61 may beconfigured to alter the pitch angle of the table 38 relative to thecolumn 37 in multiple degrees of freedom. The pitch rotation mechanism61 may be enabled by the positioning of orthogonal axes 1, 2 at thecolumn-table interface, each axis actuated by a separate motor 3, 4responsive to an electrical pitch angle command. Rotation along onescrew 5 would enable tilt adjustments in one axis 1, while rotationalong the other screw 6 would enable tilt adjustments along the otheraxis 2.

For example, pitch adjustments are particularly useful when trying toposition the table in a Trendelenburg position, i.e., position thepatient's lower abdomen at a higher position from the floor than thepatient's lower abdomen, for lower abdominal surgery. The Trendelenburgposition causes the patient's internal organs to slide towards his/herupper abdomen through the force of gravity, clearing out the abdominalcavity for minimally invasive tools to enter and perform lower abdominalsurgical procedures, such as laparoscopic prostatectomy.

C. Instrument Driver & Interface.

The end effectors of the system's robotic arms comprise (i) aninstrument driver (alternatively referred to as “instrument drivemechanism” or “instrument device manipulator”) that incorporateelectro-mechanical means for actuating the medical instrument and (ii) aremovable or detachable medical instrument which may be devoid of anyelectro-mechanical components, such as motors. This dichotomy may bedriven by the need to sterilize medical instruments used in medicalprocedures, and the inability to adequately sterilize expensive capitalequipment due to their intricate mechanical assemblies and sensitiveelectronics. Accordingly, the medical instruments may be designed to bedetached, removed, and interchanged from the instrument driver (and thusthe system) for individual sterilization or disposal by the physician orthe physician's staff. In contrast, the instrument drivers need not bechanged or sterilized, and may be draped for protection.

FIG. 12 illustrates an example instrument driver. Positioned at thedistal end of a robotic arm, instrument driver 62 comprises of one ormore drive units 63 arranged with parallel axes to provide controlledtorque to a medical instrument via drive shafts 64. Each drive unit 63comprises an individual drive shaft 64 for interacting with theinstrument, a gear head 65 for converting the motor shaft rotation to adesired torque, a motor 66 for generating the drive torque, an encoder67 to measure the speed of the motor shaft and provide feedback to thecontrol circuitry, and control circuitry 68 for receiving controlsignals and actuating the drive unit. Each drive unit 63 beingindependent controlled and motorized, the instrument driver 62 mayprovide multiple (four as shown in FIG. 12) independent drive outputs tothe medical instrument. In operation, the control circuitry 68 wouldreceive a control signal, transmit a motor signal to the motor 66,compare the resulting motor speed as measured by the encoder 67 with thedesired speed, and modulate the motor signal to generate the desiredtorque.

For procedures that require a sterile environment, the robotic systemmay incorporate a drive interface, such as a sterile adapter connectedto a sterile drape, that sits between the instrument driver and themedical instrument. The chief purpose of the sterile adapter is totransfer angular motion from the drive shafts of the instrument driverto the drive inputs of the instrument while maintaining physicalseparation, and thus sterility, between the drive shafts and driveinputs. Accordingly, an example sterile adapter may comprise of a seriesof rotational inputs and outputs intended to be mated with the driveshafts of the instrument driver and drive inputs on the instrument.Connected to the sterile adapter, the sterile drape, comprised of athin, flexible material such as transparent or translucent plastic, isdesigned to cover the capital equipment, such as the instrument driver,robotic arm, and cart (in a cart-based system) or table (in atable-based system). Use of the drape would allow the capital equipmentto be positioned proximate to the patient while still being located inan area not requiring sterilization (i.e., non-sterile field). On theother side of the sterile drape, the medical instrument may interfacewith the patient in an area requiring sterilization (i.e., sterilefield).

D. Medical Instrument.

FIG. 13 illustrates an example medical instrument with a pairedinstrument driver. Like other instruments designed for use with arobotic system, medical instrument 70 comprises an elongated shaft 71(or elongate body) and an instrument base 72. The instrument base 72,also referred to as an “instrument handle” due to its intended designfor manual interaction by the physician, may generally compriserotatable drive inputs 73, e.g., receptacles, pulleys or spools, thatare designed to be mated with drive outputs 74 that extend through adrive interface on instrument driver 75 at the distal end of robotic arm76. When physically connected, latched, and/or coupled, the mated driveinputs 73 of instrument base 72 may share axes of rotation with thedrive outputs 74 in the instrument driver 75 to allow the transfer oftorque from drive outputs 74 to drive inputs 73. In some embodiments,the drive outputs 74 may comprise splines that are designed to mate withreceptacles on the drive inputs 73.

The elongated shaft 71 is designed to be delivered through either ananatomical opening or lumen, e.g., as in endoscopy, or a minimallyinvasive incision, e.g., as in laparoscopy. The elongated shaft 66 maybe either flexible (e.g., having properties similar to an endoscope) orrigid (e.g., having properties similar to a laparoscope) or contain acustomized combination of both flexible and rigid portions. Whendesigned for laparoscopy, the distal end of a rigid elongated shaft maybe connected to an end effector comprising a jointed wrist formed from aclevis with an axis of rotation and a surgical tool, such as, forexample, a grasper or scissors, that may be actuated based on force fromthe tendons as the drive inputs rotate in response to torque receivedfrom the drive outputs 74 of the instrument driver 75. When designed forendoscopy, the distal end of a flexible elongated shaft may include asteerable or controllable bending section that may be articulated andbent based on torque received from the drive outputs 74 of theinstrument driver 75.

Torque from the instrument driver 75 is transmitted down the elongatedshaft 71 using tendons within the shaft 71. These individual tendons,such as pull wires, may be individually anchored to individual driveinputs 73 within the instrument handle 72. From the handle 72, thetendons are directed down one or more pull lumens within the elongatedshaft 71 and anchored at the distal portion of the elongated shaft 71.In laparoscopy, these tendons may be coupled to a distally mounted endeffector, such as a wrist, grasper, or scissor. Under such anarrangement, torque exerted on drive inputs 73 would transfer tension tothe tendon, thereby causing the end effector to actuate in some way. Inlaparoscopy, the tendon may cause a joint to rotate about an axis,thereby causing the end effector to move in one direction or another.Alternatively, the tendon may be connected to one or more jaws of agrasper at distal end of the elongated shaft 71, where tension from thetendon cause the grasper to close.

In endoscopy, the tendons may be coupled to a bending or articulatingsection positioned along the elongated shaft 71 (e.g., at the distalend) via adhesive, control ring, or other mechanical fixation. Whenfixedly attached to the distal end of a bending section, torque exertedon drive inputs 73 would be transmitted down the tendons, causing thesofter, bending section (sometimes referred to as the articulablesection or region) to bend or articulate. Along the non-bendingsections, it may be advantageous to spiral or helix the individual pulllumens that direct the individual tendons along (or inside) the walls ofthe endoscope shaft to balance the radial forces that result fromtension in the pull wires. The angle of the spiraling and/or spacingthere between may be altered or engineered for specific purposes,wherein tighter spiraling exhibits lesser shaft compression under loadforces, while lower amounts of spiraling results in greater shaftcompression under load forces, but also exhibits limits bending. On theother end of the spectrum, the pull lumens may be directed parallel tothe longitudinal axis of the elongated shaft 71 to allow for controlledarticulation in the desired bending or articulable sections.

In endoscopy, the elongated shaft 71 houses a number of components toassist with the robotic procedure. The shaft may comprise of a workingchannel for deploying surgical tools, irrigation, and/or aspiration tothe operative region at the distal end of the shaft 71. The shaft 71 mayalso accommodate wires and/or optical fibers to transfer signals to/froman optical assembly at the distal tip, which may include of an opticalcamera. The shaft 71 may also accommodate optical fibers to carry lightfrom proximally-located light sources, such as light emitting diodes, tothe distal end of the shaft.

At the distal end of the instrument 70, the distal tip may also comprisethe opening of a working channel for delivering tools for diagnosticand/or therapy, irrigation, and aspiration to an operative site. Thedistal tip may also include a port for a camera, such as a fiberscope ora digital camera, to capture images of an internal anatomical space.Relatedly, the distal tip may also include ports for light sources forilluminating the anatomical space when using the camera.

In the example of FIG. 13, the drive shaft axes, and thus the driveinput axes, are orthogonal to the axis of the elongated shaft. Thisarrangement, however, complicates roll capabilities for the elongatedshaft 71. Rolling the elongated shaft 71 along its axis while keepingthe drive inputs 73 static results in undesirable tangling of thetendons as they extend off the drive inputs 73 and enter pull lumenswithin the elongate shaft 71. The resulting entanglement of such tendonsmay disrupt any control algorithms intended to predict movement of theflexible elongate shaft during an endoscopic procedure.

FIG. 14 illustrates an alternative design for an instrument driver andinstrument where the axes of the drive units are parallel to the axis ofthe elongated shaft of the instrument. As shown, a circular instrumentdriver 80 comprises four drive units with their drive outputs 81 alignedin parallel at the end of a robotic arm 82. The drive units, and theirrespective drive outputs 81, are housed in a rotational assembly 83 ofthe instrument driver 80 that is driven by one of the drive units withinthe assembly 83. In response to torque provided by the rotational driveunit, the rotational assembly 83 rotates along a circular bearing thatconnects the rotational assembly 83 to the non-rotational portion 84 ofthe instrument driver. Power and controls signals may be communicatedfrom the non-rotational portion 84 of the instrument driver 80 to therotational assembly 83 through electrical contacts may be maintainedthrough rotation by a brushed slip ring connection (not shown). In otherembodiments, the rotational assembly 83 may be responsive to a separatedrive unit that is integrated into the non-rotatable portion 84, andthus not in parallel to the other drive units. The rotational mechanism83 allows the instrument driver 80 to rotate the drive units, and theirrespective drive outputs 81, as a single unit around an instrumentdriver axis 85.

Like earlier disclosed embodiments, an instrument 86 may comprise of anelongated shaft portion 88 and an instrument base 87 (shown with atransparent external skin for discussion purposes) comprising aplurality of drive inputs 89 (such as receptacles, pulleys, and spools)that are configured to receive the drive outputs 81 in the instrumentdriver 80. Unlike prior disclosed embodiments, instrument shaft 88extends from the center of instrument base 87 with an axis substantiallyparallel to the axes of the drive inputs 89, rather than orthogonal asin the design of FIG. 13.

When coupled to the rotational assembly 83 of the instrument driver 80,the medical instrument 86, comprising instrument base 87 and instrumentshaft 88, rotates in combination with the rotational assembly 83 aboutthe instrument driver axis 85. Since the instrument shaft 88 ispositioned at the center of instrument base 87, the instrument shaft 88is coaxial with instrument driver axis 85 when attached. Thus, rotationof the rotational assembly 83 causes the instrument shaft 88 to rotateabout its own longitudinal axis. Moreover, as the instrument base 87rotates with the instrument shaft 88, any tendons connected to the driveinputs 89 in the instrument base 87 are not tangled during rotation.Accordingly, the parallelism of the axes of the drive outputs 81, driveinputs 89, and instrument shaft 88 allows for the shaft rotation withouttangling any control tendons.

E. Navigation and Control.

Traditional endoscopy may involve the use of fluoroscopy (e.g., as maybe delivered through a C-arm) and other forms of radiation-based imagingmodalities to provide endoluminal guidance to an operator physician. Incontrast, the robotic systems contemplated by this disclosure canprovide for non-radiation-based navigational and localization means toreduce physician exposure to radiation and reduce the amount ofequipment within the operating room. As used herein, the term“localization” may refer to determining and/or monitoring the positionof objects in a reference coordinate system. Technologies such aspre-operative mapping, computer vision, real-time EM tracking, and robotcommand data may be used individually or in combination to achieve aradiation-free operating environment. In other cases, whereradiation-based imaging modalities are still used, the pre-operativemapping, computer vision, real-time EM tracking, and robot command datamay be used individually or in combination to improve upon theinformation obtained solely through radiation-based imaging modalities.

FIG. 15 is a block diagram illustrating a localization system 90 thatestimates a location of one or more elements of the robotic system, suchas the location of the instrument, in accordance to an exampleembodiment. The localization system 90 may be a set of one or morecomputer devices configured to execute one or more instructions. Thecomputer devices may be embodied by a processor (or processors) andcomputer-readable memory in one or more components discussed above. Byway of example and not limitation, the computer devices may be in thetower 30 shown in FIG. 1, the cart shown in FIGS. 1-4, the beds shown inFIGS. 5-10, etc.

As shown in FIG. 15, the localization system 90 may include alocalization module 95 that processes input data 91-94 to generatelocation data 96 for the distal tip of a medical instrument. Thelocation data 96 may be data or logic that represents a location and/ororientation of the distal end of the instrument relative to a frame ofreference. The frame of reference can be a frame of reference relativeto the anatomy of the patient or to a known object, such as an EM fieldgenerator (see discussion below for the EM field generator).

The various input data 91-94 are now described in greater detail.Pre-operative mapping may be accomplished through the use of thecollection of low dose CT scans. Pre-operative CT scans arereconstructed into three-dimensional images, which are visualized, e.g.as “slices” of a cutaway view of the patient's internal anatomy. Whenanalyzed in the aggregate, image-based models for anatomical cavities,spaces and structures of the patient's anatomy, such as a patient lungnetwork, may be generated. Techniques such as center-line geometry maybe determined and approximated from the CT images to develop athree-dimensional volume of the patient's anatomy, referred to as modeldata 91 (also referred to as “preoperative model data” when generatedusing only preoperative CT scans). The use of center-line geometry isdiscussed in U.S. patent application Ser. No. 14/523,760, the contentsof which are herein incorporated in its entirety. Network topologicalmodels may also be derived from the CT-images, and are particularlyappropriate for bronchoscopy.

In some embodiments, the instrument may be equipped with a camera toprovide vision data 92. The localization module 95 may process thevision data to enable one or more vision-based location tracking. Forexample, the preoperative model data may be used in conjunction with thevision data 92 to enable computer vision-based tracking of the medicalinstrument (e.g., an endoscope or an instrument advance through aworking channel of the endoscope). For example, using the preoperativemodel data 91, the robotic system may generate a library of expectedendoscopic images from the model based on the expected path of travel ofthe endoscope, each image linked to a location within the model.Intra-operatively, this library may be referenced by the robotic systemin order to compare real-time images captured at the camera (e.g., acamera at a distal end of the endoscope) to those in the image libraryto assist localization.

Other computer vision-based tracking techniques use feature tracking todetermine motion of the camera, and thus the endoscope. Some feature ofthe localization module 95 may identify circular geometries in thepreoperative model data 91 that correspond to anatomical lumens andtrack the change of those geometries to determine which anatomical lumenwas selected, as well as the relative rotational and/or translationalmotion of the camera. Use of a topological map may further enhancevision-based algorithms or techniques.

Optical flow, another computer vision-based technique, may analyze thedisplacement and translation of image pixels in a video sequence in thevision data 92 to infer camera movement. Examples of optical flowtechniques may include motion detection, object segmentationcalculations, luminance, motion compensated encoding, stereo disparitymeasurement, etc. Through the comparison of multiple frames overmultiple iterations, movement and location of the camera (and thus theendoscope) may be determined.

The localization module 95 may use real-time EM tracking to generate areal-time location of the endoscope in a global coordinate system thatmay be registered to the patient's anatomy, represented by thepreoperative model. In EM tracking, an EM sensor (or tracker) comprisingof one or more sensor coils embedded in one or more locations andorientations in a medical instrument (e.g., an endoscopic tool) measuresthe variation in the EM field created by one or more static EM fieldgenerators positioned at a known location. The location informationdetected by the EM sensors is stored as EM data 93. The EM fieldgenerator (or transmitter), may be placed close to the patient to createa low intensity magnetic field that the embedded sensor may detect. Themagnetic field induces small currents in the sensor coils of the EMsensor, which may be analyzed to determine the distance and anglebetween the EM sensor and the EM field generator. These distances andorientations may be intra-operatively “registered” to the patientanatomy (e.g., the preoperative model) in order to determine thegeometric transformation that aligns a single location in the coordinatesystem with a position in the pre-operative model of the patient'sanatomy. Once registered, an embedded EM tracker in one or morepositions of the medical instrument (e.g., the distal tip of anendoscope) may provide real-time indications of the progression of themedical instrument through the patient's anatomy.

Robotic command and kinematics data 94 may also be used by thelocalization module 95 to provide localization data 96 for the roboticsystem. Device pitch and yaw resulting from articulation commands may bedetermined during pre-operative calibration. Intra-operatively, thesecalibration measurements may be used in combination with known insertiondepth information to estimate the position of the instrument.Alternatively, these calculations may be analyzed in combination withEM, vision, and/or topological modeling to estimate the position of themedical instrument within the network.

As FIG. 15 shows, a number of other input data can be used by thelocalization module 95. For example, although not shown in FIG. 15, aninstrument utilizing shape-sensing fiber can provide shape data that thelocalization module 95 can use to determine the location and shape ofthe instrument.

The localization module 95 may use the input data 91-94 incombination(s). In some cases, such a combination may use aprobabilistic approach where the localization module 95 assigns aconfidence weight to the location determined from each of the input data91-94. Thus, where the EM data may not be reliable (as may be the casewhere there is EM interference) the confidence of the locationdetermined by the EM data 93 can be decrease and the localization module95 may rely more heavily on the vision data 92 and/or the roboticcommand and kinematics data 94.

As discussed above, the robotic systems discussed herein may be designedto incorporate a combination of one or more of the technologies above.The robotic system's computer-based control system, based in the tower,bed and/or cart, may store computer program instructions, for example,within a non-transitory computer-readable storage medium such as apersistent magnetic storage drive, solid state drive, or the like, that,upon execution, cause the system to receive and analyze sensor data anduser commands, generate control signals throughout the system, anddisplay the navigational and localization data, such as the position ofthe instrument within the global coordinate system, anatomical map, etc.

2. Directed Fluidics

Embodiments of the disclosure relate to systems and techniques forremoving an object from a treatment site of a patient, and in particularto methods and systems that employ directed fluidics during an objectremoval procedure.

During object removal procedures, fluidics (e.g., irrigation (inflow)and/or aspiration (outflow) of a liquid, such as saline) may be appliedto the treatment site. During percutaneous nephrolithotomy (PCNL), forexample, fluidics can be used to clear the visual field of stone dustand small fragments caused by the breakup of the kidney stone. Asdiscussed in greater detail below, however, the conventional approach tofluidics during object removal procedures can also cause complications.For example, irrigation may create currents within the treatment sitethat move the object to be removed away from the medical instrumentsused during the procedure.

As used herein, the term “directed fluidics” applies to the methods,techniques, and systems described in this disclosure that improve onconventional fluidics, facilitate object removal procedures, and/orresolve or alleviate one or more problems associated with conventionalobject removal procedures. In general, directed fluidics involvescontrolling various features of the flow (e.g., rate, direction,pressure, position, etc.) of irrigation and/or aspiration, and/orseparating an inflow point (or points) of irrigation from an outflowpoint (or points) of aspiration to facilitate an object removalprocedure. In some examples, directed fluidics involves providingirrigation and aspiration through a single medical instrument (e.g. apercutaneously inserted medical instrument), and may also involvecontrolling features of the irrigation and aspiration to facilitateobject removal. In some examples, directed fluidics involves controllinga flow direction from an inflow point to an outflow point so as to, forexample, hold or stabilize an object during the procedure. These andother features of directed fluidics, as well as various methods andsystems for implementing directed fluidics during an object removalprocedure, will become apparent from the following detailed descriptionof several examples. The following examples are intended to illustratethe principles of this disclosure and should not be construed aslimiting the disclosure.

In several of the examples described herein, the object removalprocedure relates to removal of kidney stones from a kidney. Thisdisclosure, however, is not limited only to kidney stone removal. Forexample, the following description is also applicable to other surgicalor medical operations or medical procedures concerned with the removalof objects from a patient, including any object that can be removed froma treatment site or patient cavity (e.g., the esophagus, ureter,intestine, eye, etc.) via percutaneous and/or endoscopic access, suchas, for example, gallbladder stone removal, lung(pulmonary/transthoracic) tumor biopsy, or cataract removal.

A. Background Discussion of Object Removal.

As mentioned above, object removal is a common surgical operation ormedical procedure. To better understand the features and advantages ofthe methods and systems for object removal that employ directed fluidicsas described herein, this section first presents background informationrelated to certain object removal procedures. By way of example,procedures for removing a kidney stone from a kidney are described.

Generally, there are several methods for treating patients with kidneystones, including observation, medical treatments (such as expulsiontherapy), non-invasive treatments (such as extracorporeal shock wavelithotripsy (ESWL), and surgical treatments (such as ureteroscopy andPCNL). In the two surgical approaches (ureteroscopy and PCNL), thephysician gains access to the pathology (i.e., the object to be removed;e.g., the stone), energy is delivered to the stone to break it intosmaller pieces or fragments, and the small stone fragments/particulatesare mechanically extracted from the kidney.

A component of PCNL is the use of fluidics (irrigation and aspiration).During PCNL, fluidics are applied to clear stone dust, small fragments,and thrombus from the treatment site as well as the visual fieldprovided by the medical instruments.

FIG. 16 illustrates an example procedure for removing an object 101 froma kidney 103 using a medical instrument 100 inserted into the kidney 103percutaneously. The illustrated example may be representative of a PCNLprocedure. The object 101 can be any object that is targeted forremoval, such as a kidney stone. In the illustrated example, the medicalinstrument 100 comprises a laparoscope or nephroscope 105. Thenephroscope 105 can be inserted percutaneously into the kidney 103through an access sheath 107. The nephroscope 105 can include a workingchannel 108, though which various tools can be inserted. As illustrated,a lithotripter 109 (such as an ultrasonic lithotripter) can be insertedthrough the working channel 108 of the nephroscope 105. The nephroscope105 can also include an optic configured to allow a surgeon to visualizethe treatment site. A field of view 117 of the optic is illustrated.

In general, the medical instrument 100 is navigated within the kidney103 by torqueing the medical instrument 100 towards the object 101. Thesurgeon's goal is to touch the distal end 121 of the lithotripter 109 tothe object 101 to break the object 101 into smaller fragments that canthen be removed.

As illustrated with arrows in FIG. 16, irrigation (for example, of asaline solution) can be applied to the treatment site (e.g., the kidney103) through the medical instrument 100. In this example, irrigationpasses through the nephroscope 105, exiting through a distal tip 113into the kidney 103. Irrigation can be used to clear stone dust andsmall fragments from the field of view 117 to allow the surgeon tovisualize the treatment site, as well as to distend the kidney 103 toallow access to the object 101. In the illustrated example, aspirationis also applied to the treatment site through the medical instrument100. As shown, liquid can be removed from the kidney 103 through theaccess sheath 107 as well as through a channel in the lithotripter 109.In some instances, irrigation is pumped (actively) through thelithotripter 109, while the remainder of the irrigation through theaccess sheath 107 is passive (e.g., passively flowing through the accesssheath 107). In some examples, fluidics are applied during the entireprocedure.

The fluidics applied during the procedure can establish a fluid flow asillustrated by the arrows in FIG. 16. Initially, fluid can flow outwardfrom the distal tip 113 of the nephroscope 105 towards the object 101.Irrigation through the access sheath 107 and lithotripter 109 can causefluid flow back towards the medical instrument 100. As illustrated, inthe region of the object 101, the flow is both directed toward and awayfrom the object 101 with respect to the distal end of the medicalinstrument 100. In some instances, the net effect of such a flow may bethat many small and unpredictable eddies 119 are formed around theobject 101 and the distal end of the medical instrument 100. This mayresult in the object 101 being pushed away from the medical instrument100. This can prevent the surgeon from contacting the lithotripter 109to the object 101 and/or scatter the fragments created by thelithotripter 109 as the stone is broken up. These difficulties may arisewhen only irrigation is actively managed, while aspiration is passive,thus not allowing for a high degree of fluidic control during theprocedure. Another potential danger is that the kidney 103 may becomeoverfilled.

As another example, during a ureteroscopic lithotripsy, a ureteroscopemay enter the kidney through the ureter and use stone-retrieval basketsand lithotripters to relocate and break down kidney stones,respectively. For example, a lithotripter can be deployed through theureteroscope and used to break the stone into fragments. During thelithotripsy of the kidney stones, several problems can occur. Forexample, the lithotripter (which applies energy to break up the stone)can cause the stone to move around unpredictably within the kidney.Further, as described above, lithotripsy generates stone dust, which canobstruct vision within the treatment site. After the stone has beenbroken down, the lithotripter can be removed and a basketing device canbe deployed through the ureteroscope to retrieve the stone fragments.This process can be both tedious and time consuming. After attempting toremove all stone fragments by basketing, there may be small stone debristhat remain.

The procedures for kidney stone removal discussed above (PCNL andureteroscopy) may exhibit certain challenges or complications. Forexample, PCNL may use fluidics that create currents within the kidneythat can move the object and fragments away from medical instrument,complicating the removal process. Ureteroscopy may use a lithotripteremployed through a ureteroscope to break up the kidney stone; however,there may be no mechanism in place to stabilize the stone duringlithotripsy. Often, the energy used to break up the stone causes thestone to bounce away from the lithotripter, complicating removal.Further, as the stone is broken down via lithotripsy, stone dust isgenerated which obstructs vision of the treatment site. Anotherchallenge with these procedures is that it may be difficult for thephysician to gain access to the treatment site because of thesurrounding anatomy outside of the kidney. For example, locations forpercutaneous access to the kidney may be limited due to the surroundinganatomy outside of the kidney.

B. Overview of Object Removal with Directed Fluidics.

The methods and systems described herein may be used to alleviate orresolve one or more of the problems of PCNL and ureteroscopy (describedabove) through the use of directed fluidics. In some embodiments,directed fluidics can be applied such that irrigation (inflow) entersthe treatment site through a first channel of a first medical device(e.g., a percutaneously inserted medical instrument) and aspiration(outflow) exits the treatment site through a second channel of the firstmedical instrument. In some embodiments, irrigation and aspiration canboth be active. In some embodiments, irrigation and aspiration can bemanaged to produce desirable flow characteristics. In some embodiments,a second medical instrument that does not provide irrigation oraspiration can also be used during the procedure, for example, to breakup the object being removed. In some embodiments, directed fluidics canbe applied such that irrigation (inflow) enters the treatment sitethrough a first medical device (e.g., a catheter or endoscope), whileaspiration (outflow) exits the treatment site through a second medicalinstrument (e.g., a catheter or endoscope). This can create a controlledflow from the first instrument towards the second instrument. Thecontrolled flow can facilitate object removal. The first medicalinstrument can be inserted into the treatment site antegrade of theobject to be removed, while the second medical instrument can beinserted into the treatment site retrograde of the object. The firstmedical instrument can be inserted through a patient lumen orpercutaneously. The second medical instrument can be inserted through apatient lumen or percutaneously. In some embodiments, the first medicalinstrument is inserted into the treatment site (e.g., the kidney)through a patient lumen (e.g., the ureter) and the second medicalinstrument is inserted into the treatment site percutaneously, or viceversa.

One or both of the first and second medical instruments can berobotically controlled medical instruments as described above withreference to FIGS. 1-15. Accordingly, the methods and systems describedbelow can be employed robotically in some embodiments.

In some instances, directed fluidics can include the separation of thepoint(s) of inflow (irrigation) from the point(s) of outflow(aspiration). The inflow can be directed towards the point of outflow,for example by deflecting the distal end of a first medical instrumenttowards a second medical instrument such that the fluid flow is towardsthe second medical instrument. This may be accomplished roboticallyand/or automatically with the systems and instruments described abovewith reference to FIGS. 1-15. In some embodiments, the point of inflow(irrigation) does not need to be directional (i.e., pointed in aspecific direction), provided that the first medical instrument isconfigured to achieve a sufficiently high inflow rate without causingturbulence. This may allow the treatment site (e.g., the kidney) to fillup with fluid without displacing the stone. In some embodiments, thepoint of outflow (aspiration) may be a single or concentrated point. Thepoint of outflow may be configured to provide high flow with highvelocities so as to cause fragments to be pulled towards the point ofoutflow.

In some embodiments, the irrigation and aspiration rates can bemodulated to improve stone displacement or stabilization or tointentionally create turbulence so that the irrigation reaches allcorners of the treatment site. For example, a gentle alternating cycleof irrigation and aspiration can create a lavage like effect topreferentially pull large stone debris away from calyces and towards theaspiration site. Alternatively, short pulsatile inflow and outflow couldbe used to create turbulence and ensure that smaller and lighter stonefragments do not settle on the floor of the treatment site, but insteadremain floating in the irrigant and eventually get aspirated with theoutflow.

FIG. 17 illustrates an example procedure for removing an object 101 froma kidney 103 using a first medical instrument 200 inserted into thekidney 103 through a patient lumen 202, a second medical instrument 204inserted into the kidney percutaneously, and directed fluidics. In theillustrated example of FIG. 17, the first medical instrument 200comprises an endoscope, such as a ureteroscope. The patient lumen 202can comprise the ureter. The first medical instrument 200 can include achannel for supplying irrigation. The channel can be connected to anirrigation source and a pump (see FIG. 25). The first medical instrument200 may be articulable. The first medical instrument 200 may berobotically controlled.

As illustrated, the second medical instrument 204 can include anephroscope 105. The nephroscope 105 can be a rigid nephroscope. Thenephroscope 105 can be inserted percutaneously into the kidney 103through an access sheath 107. The nephroscope 105 can include a workingchannel 108, though which various tools can be inserted or that may beused as channels for aspiration or irrigation. In some embodiments,other channels within the nephroscope can be used for aspiration andirrigation. As illustrated, a lithotripter 109 (such as an ultrasoniclithotripter) may be inserted through the working channel 108 of thenephroscope 105. The nephroscope 105 can also include an opticconfigured to allow a surgeon to visualize the treatment site. A fieldof view 117 of the optic is illustrated.

Fluid flow is illustrated with arrows in FIG. 17. As shown, irrigationis provided through the first medical instrument 200 and aspiration isprovided through the second medical instrument 204. In the illustratedembodiment, irrigation is provided through the lithotripter 109, butirrigation could be provided alternatively (or additionally) through thenephroscope 105 and/or access sheath 107. As shown, the points of inflow(irrigation) and outflow (aspiration) are separated and a general flowdirection is established from the first medical instrument 200 to thesecond medical instrument 204.

As mentioned above, the second medical instrument 204 may include anoptic (e.g., a camera) for visualizing the treatment site (with field ofview 117). Because flow is directed continuously away from the firstinstrument 200 and towards the second instrument 204, the field of view117 of the optic can remain clear, allowing improved visualization ofthe treatment site. Further, because flow is directed towards the secondmedical instrument 204, which includes the lithotripter 109, the object101 and fragments can be pushed towards the second medical instrument204, beneficially facilitating contact with the lithotripter 109.

This concept of directed fluidics allows debris, dust, thrombus, andfragments to naturally flow towards the second medical instrument 204and into the stone extraction or destruction device (lithotripter 109).In the event that the physician is required to pursue fragments, he orshe may need to maneuver the devices to a lesser extent than duringother procedures owed to the tendency of fragments to flow toward ratherthan away from the second medical device 204.

Additionally, in the event that irrigation is provided through thenephroscope 105 and/or access sheath 107, this may enable the use of amuch larger diameter lithotripter 109 because the irrigation and/oraspiration no longer need to be provided through the lithotripter 109.

In another example, the second instrument 204 can be an articulablecatheter that is introduced via percutaneous access into the treatmentsite (e.g., the kidney) (see FIGS. 18, 19, 26A, and 26B). The cathetercan be configured to be able to navigate within the kidney. For example,the catheter may be configured to be inserted and retracted into thetreatment site and/or to articulate (e.g., bend). In some embodiments,the catheter can include pull-wires for controlling articulation. Insome embodiments, four pull-wires are oriented in the four orthogonaldirections to enable articulation of the catheter. Other methods forpermitting articulation of the catheter are also possible. The cathetercan include, for example, an aspiration lumen (or channel). Theaspiration lumen can be connected to a pump. The pump may be an externalpump. The pump may generate negative pressure that causes flow from thetreatment site into the catheter. The aspiration function may be able tobe toggled (e.g., on and off) and adjusted by the user or system. Insome embodiments, the aspiration lumen may be used for irrigation.

The catheter can provide several functions during an object removalprocedure employing directed fluidics. For example, the catheter canstabilize the stone during lithotripsy. If the stone is larger than theaspiration lumen of the catheter, the stone can be held at the distalface of the aspiration lumen, thus stabilizing the stone while it isbroken down to dust and smaller fragments. The aspiration flow may holdthe stone to the distal face. This may provide the user with a lessmobile target for lithotripsy.

The catheter can improve visibility of the treatment site. The cathetercan remove stone dust from the kidney. This can provide the user withimproved visibility (e.g., continuously adequate visibility), forexample, from an imaging device inserted into the treatment site (forexample, on a medical instrument inserted into the treatment site).

The catheter can remove stone dust and fragments. The fluid flow cancarry fluid and debris into the catheter. The debris may be cleared asit is generated (i.e., while the stone is being broken up). The removalof debris via the catheter can take the place of removal of fragmentsvia ureteroscopic basketing, which can be time consuming due to thedifficulty of closing the basket around the stone, and due to the needto remove and re-insert the ureteroscope during each fragment removal.This can result in a more efficient removal procedure. Such a proceduremay be completed faster because, for example, fragments are removed asthe stone is broken up. Removing stone debris via the catheter can alsoreduce the risk of the stone fragment injuring tissue (such as duringremoval of stone through the ureter).

The catheter can be used to relocate kidney stones. For example, thecatheter can be configured to navigate within the kidney towards stoneor stone debris. With aspiration, the stone or stone debris can be heldonto the distal tip of the catheter, and moved to another locationwithin the kidney. This function may remove or reduce the need to use abasket device to relocate or move the stone. The catheter can also beconfigured to be advanced into the ureter to retrieve stones orfragments that have migrated into the ureter. This may allow a physicianto perform the procedure without ureteral protection devices that aresometimes employed during certain procedures.

The catheter can be used in several ways during a procedure. Forexample, the catheter can be mobile throughout the procedure. Thecatheter can navigate around the treatment site to target specificstones/fragments in order to constrain them during lithotripsy, whilealso aspirating dust/debris. As another example, the catheter can beinitially stationary during the procedure and the first medicalinstrument (e.g., a ureteroscope) could be used to relocate stones tothe catheter. The stones could be broken down at the catheter. At alater time during the procedure, the catheter could navigate through thetreatment site to pick up remaining debris. As another example, thecatheter could be inserted (e.g., percutaneously) only when required,for example, during procedure escalation.

FIG. 18 illustrates an example procedure for removing an object 101 froma kidney 103 using a first medical instrument 200 inserted into thekidney 103 through a patient lumen 202, a second medical instrument 204,such as a steerable catheter, inserted into the kidney 103percutaneously (for example, through an access sheath 107), and directedfluidics. Irrigation may be provided through the first medicalinstrument 200 and aspiration may be provided through the second medicalinstrument 204. In this example, the points of inflow (irrigation) andoutflow (aspiration) are separated and a general flow direction isestablished from the first medical instrument 200 towards the secondmedical instrument 204. Arrows illustrate the direction of fluid flow.

As illustrated in FIG. 18, the first medical instrument 200 can bearticulable. That is the shape or pose of the first medical instrument200 can be controlled. In some embodiments, the articulation iscontrolled robotically as described above. As illustrated, the firstmedical instrument 200 can be articulated such that the irrigation flowis oriented or directed towards the second medical instrument 204. Thismay help establish the fluid flow from the first medical instrument 200towards the second medical instrument 204.

The second medical instrument 204 (e.g., the steerable catheter) canalso be articulable. That is the shape or pose of the second medicalinstrument 204 can be controlled. In some embodiments, the articulationis controlled robotically as described above. As illustrated, the secondmedical instrument 204 can include an articulable distal tip 206. Thesecond medical instrument 204 (or the distal tip 206 thereof) can bearticulated such that that the distal tip 206 is oriented or directedtowards the first medical instrument 200 and/or the object 101. This mayhelp establish the fluid flow from the first medical instrument 200towards the second medical instrument 204, thereby serving to pull theobject 101 towards the second medical instrument 204.

FIG. 19 illustrates another example procedure for removing an object 101from a kidney 103 using a first medical instrument 200 inserted into thekidney 103 through a patient lumen 202, a second medical instrument 204(such as a steerable catheter) inserted into the kidney 103percutaneously (for example, through an access sheath 107), and directedfluidics. In the illustrated example, the first medical instrument 200includes a lithotripter 109. Fluid flow from the first medicalinstrument 200 to the second medical instrument 204 can be used to holdthe object 101 and/or fragments onto the distal tip 206 of the secondmedical instrument 204. This can stabilize the object 101 and/orfragments during lithotripsy with the lithotripter 109 of first medicalinstrument 200. The distal tip 206 of the second medical instrument 204can include a pocket (or other holding device) on its distal tip tostabilize and hold the object 101 and/or fragments. See, for example,FIGS. 26A and 26B described below.

FIG. 20 provides a detailed view of a distal tip 203 of the firstmedical instrument 200 (providing irrigation) and a distal tip 206 ofthe second medical 204 instrument (providing aspiration during) anobject removal procedure. Arrows illustrate the direction of flow fromthe first medical instrument 200 to the second medical instrument 204.As shown, irrigation passes through a first fluid channel 205 in thefirst medical instrument 200 and exits at a distal tip 203. Aspirationis provided through the distal tip 206 and second fluid channel 207. Asshown, the flow directs the object 101 towards the distal tip 206 of thesecond medical instrument 204.

In some examples, the catheter can also have the ability to provideirrigation of fluid into the kidney (in addition to the aspirationdescribed above). For example, an irrigation channel of the catheter canstart at the proximal end of the catheter and can include the annularspace between the catheter shaft and the aspiration lumen tubing. Thedistal end of the catheter can include irrigation openings. For example,the catheter can include circumferential holes (e.g. four holes) fromwhich the irrigation fluid exits. The irrigation may be toggled on/offby the user or system. The irrigation may be connected to a fluidicssystem that has the ability to balance or otherwise modify theirrigation/aspiration levels as described herein.

FIG. 21A provides a detailed view of a distal tip of a first medicalinstrument 200 providing irrigation and a distal tip 206 of a secondmedical instrument 204 providing both irrigation and aspiration duringan object removal procedure (see also FIGS. 26A and 26B describedbelow). Arrows illustrate the direction of flow from the first medicalinstrument 200 to the second medical instrument 204. As shown, in thisexample, irrigation passes through a first fluid channel 205 in thefirst medical instrument 200 and exits at a distal tip 203. Similar toFIG. 20, aspiration is provided through the distal tip 206 and secondfluid channel 207 of the second medical instrument 204. However, thesecond medical instrument 204 also includes additional fluid channels209 for supplying irrigation. The additional fluid channels 209 canannularly surround the second fluid channel 207. In the illustratedembodiments, the additional fluid channels 209 terminate at fluidoutlets 211 near the distal tip 206 of the second medical instrument204. In some embodiments, the fluid outlets 211 can direct theirrigation from the second medical instrument 204 away from the distaltip 206. In some embodiments, the fluid outlets 211 can direct theirrigation radially away from the distal tip 206. As shown, the flow candirect the object 101 towards the distal tip 206 of the second medicalinstrument 204.

In some implementations, irrigation and aspiration can be providedthrough a single medical instrument, while another medical instrumentmay be used for performing additional aspects of the procedure. Forexample, FIG. 21B provides a detailed view of a distal tip of a firstmedical instrument 200 performing lithotomy with a lithotripter 216 anda distal tip 206 of a second medical instrument 204 providing bothirrigation and aspiration during an object removal procedure. The secondmedical instrument 204 may be similar to the instrument 700 describedbelow with reference to FIGS. 26A and 26B. As shown, in this example,only the second instrument 204 is used to provide fluidics. Bothirrigation and aspiration are provided through the second instrument204.

Directed fluidics can provide one or more of the following advantages.During a ureteroscopic lithotripsy, the kidney stone can move around andmigrate within the kidney. The energy from the lithotripter mayexacerbate this movement. Directed fluidics, with or without a catheterthat provides both aspiration and irrigation, can use aspiration toconstrain these unwanted stone movements. For example, the fluid flowcan hold the stone to the distal end of the instrument.

Additionally, during lithotripsy, small dust particles form, which canobscure vision through the ureteroscope. In some ureteroscopiclithotripsy, the vision can become so obscured that the procedure mustbe stopped. Directed fluidics, with or without a catheter that providesboth aspiration and irrigation, can provide the advantage of aspiratingthe dust particles (or other matter) out of the treatment site,providing the user with continuous good visibility.

Additionally, basketing can be time consuming due to the difficulty ofcapturing stone fragments within a basket and then removing the entireureteroscope from the patient for each fragment removal. Directedfluidics can provide the advantage of quick removal of stone fragmentsas they are formed.

Finally, during some ureteroscopic lithotripsy, if a kidney stone needsto be relocated, a basket retrieval device is often used, which may betime consuming due to the need to position the stone in the basket, anddue to the need to exchange the lithotripter for the basket retrievaldevice. Directed fluidics can provide the advantage of navigating thecatheter through the kidney and using aspiration to hold onto the stone,and then relocating the stone to another location in the kidney bymoving the aspiration catheter.

C. Example Methods for Directed Fluidics.

FIG. 22A is a flowchart illustrating an embodiment of a method 300 foradministering directed fluidics during a medical procedure, such as anobject removal procedure. In some examples, the object removal procedureis a procedure for removing a kidney stone from a kidney. The method 300can be also be implemented in other types of medical procedures and inother treatment sites. In some embodiments, the method 300 isimplemented in a robotic medical system, for example, any of the systemsdescribed above with reference to FIGS. 1-15.

The method 300 begins at block 302. At block 302, a first medicalinstrument is inserted into a treatment site. The first medicalinstrument can be inserted through a lumen of the patient. In theexample of kidney stone removal, the patient lumen may be the ureter. Insome examples, the first medical instrument can be insertedpercutaneously into the treatment site. The first medical instrument canbe an endoscope, nephroscope, catheter, or other type of medicalinstrument. The first medical instrument can be articulable. In someexamples, the first medical instrument is not articulable. In someembodiments, the first medical instrument can include one or moreworking channels configured to receive various tools (e.g.,lithotripters, basket retrieval devices, forceps, etc.) therethrough.The first medical instrument can include at least one first fluidchannel. The first fluid channel can be configured to provide fluidicsto the treatment site during the medical procedure.

At block 304, a second medical instrument is inserted into the treatmentsite. The second medical instrument can be inserted through a lumen ofthe patient. In the example of kidney stone removal, the patient lumenmay be the ureter. In some examples, the second medical instrument canbe inserted percutaneously into the treatment site. The second medicalinstrument can be an endoscope, nephroscope, catheter, or other type ofmedical instrument. The second medical instrument can be articulable. Insome examples, the second medical instrument is not articulable. Thesecond medical instrument can include one or more working channelsconfigured to receive various tools (e.g., lithotripters, basketretrieval devices, forceps, etc.) therethrough. The second medicalinstrument can include at least one second fluid channel. The secondfluid channel can be configured to provide fluidics to the treatmentsite during the medical procedure.

In some instances, the order of block 302 and block 304 can be reversed.In some instances, block 302 and block 304 can be performed at the sametime.

In some instances, the first and second medical devices are insertedinto the treatment site via different methods of access. For example,the first medical instrument may be inserted through a patient lumen andthe second medical instrument may be inserted percutaneously, or viceversa. As another example, the first medical instrument can be insertedinto the treatment site through a first patient lumen, and the secondmedical instrument can be inserted into the treatment side through asecond patient lumen different than the first patient lumen. As anotherexample, the first medical device can be inserted through a firstpercutaneous access, and the second medical device can be insertedthrough a second percutaneous access different than the firstpercutaneous access. In some examples, the first and second medicaldevices are inserted through the same patient lumen or through the samepercutaneous access.

In some instances, the first and second medical devices are insertedinto the treatment site such that the distal ends of the first andsecond medical devices are separated within the treatment site. Forexample, the distal end of the first medical device can be positionedantegrade of the object to be removed, and the distal end of the secondmedical device can be positioned retrograde of the object to be removed.As another example, the distal end of the medical device can bepositioned retrograde of the object to be removed, and the distal end ofthe second medical device can be positioned antegrade of the object tobe removed. In some instances, the first and second medical devices arepositioned such that the object is positioned between the distal ends ofthe first and second medical devices.

In some instances, the distal end of the first medical device can beoriented (e.g., directed or pointed) towards the distal end of thesecond medical device. Alternatively or additionally, the distal end ofthe second medical device can be oriented towards the distal end offirst medical device. In some examples, “pointing towards” can refer toa general axis or direction of fluid flow entering or exiting the firstor second fluid channel of the first or second medical instrument. Insome embodiments, the distal ends of the first and second medicaldevices can include position sensors. The position sensors can be EMsensors. The EM sensors can be configured to provide positioninformation regarding the distal ends of the first and second medicaldevices and/or orientation information regarding the distal ends of thefirst and second medical devices. Other types of position andorientation sensors can be used. An output of the position sensors maybe used to orient that first and second medical instruments. In someembodiments, the first and second medical instruments can be orientedvisually or through other methods.

In some instances, the distal end of the first medical instrument can bebrought into contact with the object to be removed. Alternatively oradditionally, the distal end of the second medical instrument can bebrought into contact with the object to be removed. In some embodiments,neither instrument contacts the object to be removed.

At block 306, irrigation is provided through the first medicalinstrument. For example, irrigation can be provided through the firstfluid channel of the first medical instrument. The first fluid channelcan be connected to an irrigation source through a pump. The irrigationsource can provide a fluid irrigant (such as saline) for irrigating thetreatment site. The pump can be configured to move the irrigant throughthe fluid channel and into the treatment site. In one example, the pumpis a peristaltic pump. The pump can be configured to set a specificflowrate through the first medical instrument. In another example, thepump can be a vacuum source configured to apply a negative pressure thatdraws the irrigant from the irrigation source, out through the firstmedical instrument, and into the treatment site. Flow rate can be variedby adjusting the vacuum pressure.

At block 308, aspiration is provided through the second medicalinstrument. For example, aspiration can be provided through the secondfluid channel of the second medical instrument. The second fluid channelcan be connected to a collection container through a vacuum. The vacuumcan be configured to apply a negative pressure that draws the fluid(e.g., the irrigant) from the treatment site, through the second medicalinstrument, and into the collection container. Flow rate can be variedby adjusting the vacuum pressure. In another example, the vacuum can bereplaced with a pump, such as peristaltic pump. The pump can be used tomove fluid (e.g., the irrigant) from the treatment site, through thesecond medical instrument, and into the collection container. The pumpor vacuum can be configured to set a specific flowrate through thesecond medical instrument.

In some instances, the order of blocks 306 and block 308 can bereversed. In some instances, block 306 and block 308 can be performed atthe same time. In some instances, block 306 and block 308 can beperformed alternatingly, such that irrigation is provided, followed byaspiration, in a series of repetitive steps, for example.

At block 310, the method 300 determines a characteristic of either theirrigation or the aspiration. The characteristic can be an instantaneousflow rate of the irrigation or aspiration. The characteristic can be anaverage flow rate of the irrigation or aspiration over a time interval.The time interval can be, for example, 1.0 seconds, 2.5, second, 5second, 10 second, 15 seconds or longer, as well as intervals above andbelow the listed values. The characteristic can be a volume of fluidirrigated or aspirated during a time interval, such as, for example, anyof the time intervals listed above. The characteristic can be aninstantaneous fluid pressure associated with the irrigation oraspiration. The characteristic can be an average fluid pressureassociated with the irrigation or aspiration over a time interval, suchas, for example, any of the time intervals listed above. The fluidpressure can be, for example, a fluid pressure within the first fluidchannel, a fluid pressure within the second fluid channel, or a fluidpressure within the treatment site itself.

In some instances, the characteristic is determined using one or moresensors. The sensor can be positioned, for example, in the first fluidchannel, on the first medical instrument, in the second fluid channel,on the second medical instrument, or otherwise within in the treatmentsite. The sensor can be a flow rate sensor, a pressure sensor, or othersensor for determining a characteristic of the irrigation or aspiration.In some embodiments, the sensor can measure intrarenal pressure. In someinstances, the characteristic is determined from the pump or vacuumsource supplying the irrigation or aspiration. For example, thecharacteristic can be determined based on a flow rate set by the pump ora vacuum pressure applied by the vacuum source. In some instances, thecharacteristic is calculated from one or more known or measuredparameters. For example, the characteristic can comprise a volume ofirrigant within the treatment site calculated based on the amount ofirrigant pumped into the treatment site.

At block 312, the method 300 selects (e.g., sets or adjusts) acharacteristic of the other of the irrigation or aspiration based on thecharacteristic of the irrigation or aspiration determined at block 310.For example, if a characteristic of aspiration of is determined at block310, a characteristic of irrigation is selected at block 312 based onthe determined characteristic. If a characteristic of irrigation of isdetermined at block 310, a characteristic of aspiration is selected atblock 312 based on the determined characteristic.

The selected characteristic may be any of the characteristics describedabove with reference to the determined characteristic of block 310. Forexample, the selected characteristic can be instantaneous or averageflow rate, fluid volume, pressure, etc.

In some instances, the selected characteristic may correspond with thedetermined characteristic. For example, if instantaneous flow rate ofthe irrigation is determined, flow rate of the aspiration is selected.This need not be the case in all instances. For example, a volume ofirrigation can be determined and an instantaneous flow rate or pressureassociated with aspiration can be adjusted. In some instances, theselected characteristic is selected to match the determinedcharacteristic. For example, if a flow rate of x mL/sec of irrigation isdetermined, the flow rate of aspiration can be selected to match that isthe flow rate of aspiration can be selected to be x mL/sec, such thatthe flow rates of irrigation and aspiration match. This need not be thecase in all embodiments. For example, if a flow rate of x mL/sec ofirrigation is determined, the flow rate of aspiration can be selectedbased on the determined flow rate, without exactly matching—that is theflow rate of aspiration can be selected to be y mL/sec, such that theflow rates of irrigation and aspiration do not exactly match. In someembodiments, the determined and selected characteristics are related butdo not exactly match. For example, the flow rate of aspiration can begreater than, less than, or equal to the flow rate of irrigation.

With blocks 310 and 312, one of aspiration and irrigation can beadjusted based on the other of aspiration or irrigation. The method 300thus provides a way for balancing (e.g., instantaneously or over aperiod of time) aspiration and irrigation. The method 300 also providesa mechanism for regulating a condition of the treatment site. Forexample, by balancing irrigation and aspiration, an internal fluidvolume or pressure of the treatment site can be adjusted or maintained.The method 300 also provides a mechanism for regulating a condition ofthe fluid flow. For example, by balancing irrigation and aspiration,flow rate between the first medical instrument and the second medicalinstrument can be adjusted or maintained. Other fluid flowcharacteristics can be adjusted or generated with the method 300 by, forexample, pulsing the aspiration and/or irrigation.

Because fluid flow through the treatment site created by the method 300is generally from the first medical instrument towards the secondmedical instrument, the method 300 is capable of achieving many of theadvantages and benefits of directed fluidics previously described. Forexample, the method 300 can be used to keep a field of view clear, drawthe stone (or fragments thereof) towards the second medical instrumentfor aspiration, hold the stone (or fragments thereof) in place duringlithotripsy, and/or permit movement or relocation of the stone (orfragments thereof) by holding the stone to the distal end of the secondmedical instrument.

The method 300 can include additional steps or blocks not illustrated inFIG. 22A. For example, the method 300 can include determining acharacteristic of the treatment site. The characteristic of thetreatment site can be, for example, a volume of fluid within thetreatment site or a pressure within the treatment site. The determinedcharacteristic of the treatment site can be determined with a sensor orcan be calculated based on one or more characteristics of the irrigationand/or aspiration. In some embodiments, the determined characteristic ofthe treatment site is internal pressure of the treatment site, which canbe determined based on irrigation and aspiration pressure and/orirrigation and aspiration flow rate.

In some instances, the determined characteristic of the treatment sitecan be compared to a threshold value. Upon determination that thedetermined characteristic meets or exceeds the threshold value, themethod can include at least one of reducing irrigation into thetreatment site, increasing aspiration from the treatment site, andproviding an alert. For example, if the internal pressure of thetreatment site is determined to be too high, the irrigation can bedecreased and/or the aspiration can be increased in order to lower thepressure within the treatment site. An alarm can also be provided to thephysician.

The method 300 may also include the step of moving a distal tip of thefirst medical instrument and/or the second medical instrument in asweeping motion while providing irrigation or aspiration. That is,distal tip of the first medical instrument and/or the second medicalinstrument can be moved in a dithering motion.

The method 300 can also include performing lithotripsy on an objectwithin the treatment site to break the object into fragments.Lithotripsy can be performed with a lithotripter inserted through thefirst or second medical instruments. The method 300 can also includeaspirating the fragments of the object through the second fluid channelof the second medical instrument. In some instances, the second medicalinstrument is navigated around the treatment site to collect thefragments. In some instances, the fluid flow from the first medicalinstrument towards the second medical instruments carries the fragmentsto the second medical instrument for aspiration.

As noted previously, the second medical instrument can be a steerablemedical instrument comprising an articulable distal end. The method 300can include contacting the distal end to an object within the treatmentsite. Contacting the distal end can include articulating or navigatingthe distal end to the object. Contacting the distal end to the objectcan include drawing the object to the distal end with fluid flow. Themethod 300 can also include providing aspiration through the secondfluid channel to hold the object to the distal end of the second medicalinstrument. The distal end can include a pocket configured to hold theobject. The method 300 can further include performing lithotripsy whilethe object is held to the distal end of the second medical instrument.The method 300 can further include moving the second medical instrument,while the object is held to the distal end, to reposition the objectwithin the treatment site.

In addition to providing irrigation through the first medical instrumentat block 306 and aspiration through the second medical instrument 308,the method 300 may also include providing irrigation through the secondmedical instrument. The second medical instrument can include one ormore additional fluid channels for providing irrigation, in addition tothe second fluid channel for providing aspiration. See, for example, thedevice of FIGS. 26A, and 26B.

FIG. 22B is a flowchart illustrating an embodiment of another method 350for administering directed fluidics during a medical procedure, such asan object removal procedure. In some examples, the object removalprocedure is a procedure for removing a kidney stone from a kidney. Themethod 350 can be also be implemented in other types of medicalprocedures and in other treatment sites. In some embodiments, the method350 is implemented in a robotic medical system, for example, any of thesystems described above with reference to FIGS. 1-15.

In the method 350, both irrigation and aspiration are provided through asingle medical instrument, for example, as described above, for example,with reference to FIG. 21B. The medical instrument can be similar to themedical instrument 700 described below with reference to FIGS. 26A and26B.

The method 350 begins at block 350. At block 352, a first medicalinstrument is inserted into a treatment site. The first medicalinstrument can be inserted through a lumen of the patient. In theexample of kidney stone removal, the patient lumen may be the ureter. Insome examples, the first medical instrument can be insertedpercutaneously into the treatment site. The first medical instrument canbe an endoscope, nephroscope, catheter, or other type of medicalinstrument. The first medical instrument can be articulable. In someexamples, the first medical instrument is not articulable. In someembodiments, the first medical instrument can include one or moreworking channels configured to receive various tools (e.g.,lithotripters, basket retrieval devices, forceps, etc.) therethrough.The first medical instrument can include at least one first fluidchannel and at least one second fluid channel. The first fluid channeland the second fluid channel can be configured to provide fluidics tothe treatment site during the medical procedure. In some instances, thedistal end of the first medical instrument can be brought into contactwith the object to be removed.

At block 354, irrigation is provided through the first medicalinstrument. For example, irrigation can be provided through the firstfluid channel of the first medical instrument. The first fluid channelcan be connected to an irrigation source as described above.

At block 356, aspiration is provided through the first medicalinstrument. For example, aspiration can be provided through the secondfluid channel of the first medical instrument. The second fluid channelcan be connected to a collection container through a vacuum as describedabove. In some instances, the order of block 354 and block 356 can bereversed. In some instances, block 354 and block 356 can be performed atthe same time. In some instances, block 354 and block 356 can beperformed alternatingly, such that irrigation is provided, followed byaspiration, in a series of repetitive steps, for example.

At block 358, the method 350 determines a characteristic of either theirrigation or the aspiration as described above. At block 360, themethod 350 selects (e.g., sets or adjusts) a characteristic of the otherof the irrigation or aspiration based on the characteristic of theirrigation or aspiration determined at block 358.

The method 350 illustrates that in some examples, directed fluidics canbe provided through a single medical instrument, such as the instrumentshown in FIGS. 26A and 26B. In some embodiments, a second medicalinstrument can also be employed during the procedure to perform othertasks, as described above. For example, a second instrument can be aureteroscope, through which a lithotripter can be deployed for breakingup the object to be removed.

FIG. 23 provides a flowchart illustrating an embodiment of anothermethod 400 for directed fluidics during a medical procedure, such as anobject removal procedure. In some examples, the object removal procedureis a procedure for removing a kidney stone from a kidney. The method 400can be also be implemented in other types of medical procedures and inother treatment sites. In some embodiments, the method 400 isimplemented in a robotic medical system, such as any of the systemsdescribed above with reference to FIGS. 1-15. In some instances, themethod 400 can be performed together with the method 300 of FIG. 22Aand/or the method 350 of FIG. 22B.

The method 400 begins at block 402. At block 402, a first medicalinstrument is positioned into a treatment site. The first medicalinstrument can be inserted through a lumen of the patient. In theexample of kidney stone removal, the patient lumen may be the ureter. Insome examples, the first medical instrument can be insertedpercutaneously into the treatment site. The first medical instrument canbe an endoscope, nephroscope, catheter, or other type of medicalinstrument. The first medical instrument can be articulable. In someexamples, the first medical instrument is not articulable. In someembodiments, the first medical instrument can include one or moreworking channels configured to receive various tools (e.g.,lithotripters, basketing devices, forceps, etc.) therethrough. The firstmedical instrument can include at least one first fluid channel. Thefirst fluid channel can be configured to provide fluidics to thetreatment site during the medical procedure.

At block 404, a second medical instrument is positioned into a treatmentsite. The second medical instrument can be inserted through a lumen ofthe patient. In the example of kidney stone removal, the patient lumenmay be the ureter. In some examples, the second medical instrument canbe inserted percutaneously into the treatment site. The second medicalinstrument can be an endoscope, nephroscope, catheter, or other type ofmedical instrument. The second medical instrument can be articulable. Insome examples, the second medical instrument is not articulable. Thesecond medical instrument can include one or more working channelsconfigured to receive various tools (e.g., lithotripters, basketretrieval devices, forceps, etc.) therethrough. The second medicalinstrument can include at least one second fluid channel. The secondfluid channel can be configured to provide fluidics to the treatmentsite during the medical procedure.

In some instances, the order of block 402 and block 404 can be reversed.In some instances, block 402 and block 404 can be performed at the sametime.

In some instances, the first and second medical devices are positionedinto the treatment site via different methods of access. For example,the first medical instrument may be inserted through a patient lumen andthe second medical instrument may be inserted percutaneously, or viceversa. As another example, the first medical instrument can be insertedinto the treatment site through a first patient lumen, and the secondmedical instrument can be inserted into the treatment side through asecond patient lumen different than the first patient lumen. As anotherexample, the first medical device can be inserted through a firstpercutaneous access, and the second medical device can be insertedthrough a second percutaneous access different than the firstpercutaneous access. In some examples, the first and second medicaldevices are inserted through the same patient lumen or through the samepercutaneous access.

In some instances, the first and second medical devices are positionedinto the treatment site such that the distal ends of the first andsecond medical devices are separated within the treatment site. Forexample, the distal end of the first medical device can be positionedantegrade of the object to be removed, and the distal end of the secondmedical device can be positioned retrograde of the object to be removed.As another example, the distal end of the first medical device can bepositioned retrograde of the object to be removed, and the distal end ofthe second medical device can be positioned antegrade of the object tobe removed. In some instances, the first and second medical devices arepositioned such that the object is positioned between the distal ends ofthe first and second medical devices.

At block 406, irrigation is provided through a first aperture of thefirst medical instrument in a first fluid flow direction. The firstfluid flow direction can be, in some embodiments, a direction normal tothe first aperture. The first fluid flow direction can be a general flowdirection of fluid exiting the first fluid aperture. At block 408,aspiration is provided through a second aperture in the second medicalinstrument. In some instances, the order of block 406 and block 408 canbe reversed. In some instances, block 406 and block 408 can be performedat the same time.

At block 410, the first and/or second medical instruments aremanipulated such that the first flow direction is oriented toward thesecond aperture of the second medical instrument. Manipulating the firstand/or second medical instruments can include manipulating the firstand/or second medical instruments remotely and/or robotically.Manipulating the first and/or second medical instruments can includemoving the first and/or second medical instruments such that the firstfluid flow direction is oriented towards or pointed at the second fluidaperture.

According to the method 400, the fluid flow is oriented from the firstmedical instrument toward the second medical instrument, which canprovide one or more of the benefits described above.

The method 400 can include one or more additional steps. For example,the method 400 can include determining the position and/or orientationof the distal ends of the first and/or second medical instruments. Thefirst and/or second medical instruments can include position sensors onthe distal ends thereof. The position sensors can be EM sensors. The EMsensors can be configured to provide position information regarding thedistal ends of the first and second medical devices as well asorientation information regarding the distal ends of the first andsecond medical instruments. Other types of position and orientationsensors, such as a shape sensing fiber, for example, can be used. Anoutput of the position sensors can be used to orient the first andsecond medical instruments.

In some implementations of the method 400, block 410 occursautomatically. For example, the positions and orientations of the distalends of the first and second medical instruments can be determined, andthe first and second medical instruments can be automaticallymanipulated. For example, the orientation of first medical instrumentcan be automatically manipulated so as to track the position of thesecond medical instrument. That is, as the second medical instrumentmoves, the orientation of the first medical instrument is automaticallyadjusted such that the first fluid flow direction remains pointed at ororiented toward the second medical instrument. This can help ensure thatthe fluid flow remains oriented in the proper direction.

FIG. 24 is a flowchart illustrating an embodiment of a method 500 forholding and repositioning an object using directed fluidics during amedical procedure, such as an object removal procedure. In someexamples, the object removal procedure is a procedure for removing akidney stone from a kidney. The method 500 can be also be implemented inother types of medical procedures and in other treatment sites. In someembodiments, the method 500 is implemented in a robotic medical system,such as any of the systems described above with reference to FIGS. 1-15.In some instances, the method 500 can be performed together with themethod 300 of FIG. 22A, the method 350 of FIG. 22B, and/or the method400 of FIG. 23. In some instances, the method 500 can be employed usingthe medical instrument of FIGS. 26A and 26B.

The method 500 begins at block 502. At block 502, a first medicalinstrument is positioned into a treatment site. For example, the firstmedical instrument can be inserted through a lumen of the patient. Inthe example of kidney stone removal, the patient lumen may be theureter. In some examples, the first medical instrument can be insertedpercutaneously into the treatment site. The first medical instrument canbe an endoscope, nephroscope, catheter, or other type of medicalinstrument. The first medical instrument can be articulable. In someexamples, the first medical instrument is not articulable. In someembodiments, the first medical instrument can include one or moreworking channels configured to receive various tools (e.g.,lithotripters, basket retrieval devices, forceps, etc.) therethrough.The first medical instrument can include at least one first fluidchannel. The first fluid channel can be configured to provide fluidicsto or from the treatment site during the medical procedure.

At block 504, a distal end of the first medical instrument is broughtinto contact with the object to be removed. Contacting the distal end tothe object can include articulating or navigating the distal end to theobject. In some instances, articulation or navigation of the firstmedical instrument is achieved robotically, for example, throughmanipulation of the first medical instrument with an instrument devicemanipulator or robotic arm to which the first medical instrument isattached. In some instances, articulation or guidance is controlled by aphysician controlling the robotic system. In some instances,articulation or guidance is automatically determined by the roboticsystem. For example, the robotic system can determine the position ofthe object and the first medical instrument and navigate the firstmedical instrument to the object. Contacting the distal end to theobject can include drawing the object to the distal end with fluid flow,for example with aspiration through the first medical instrument and/orirrigation provided through a second medical instrument.

At block 506, aspiration is provided through the first medicalinstrument to hold the object to the distal end of the first medicalinstrument. Aspiration can be provided with a vacuum connected to thefirst medical instrument. The vacuum can be configured to apply anegative pressure that draws the fluid from the treatment site, throughthe first medical instrument. In another example, the vacuum can bereplaced with a pump, such as peristaltic pump. The pump can be used tomove fluid from the treatment site, through the first medicalinstrument. As fluid is aspirated through the first medical instrument,the fluid flow can hold the object to the distal end of the firstmedical instrument. In some instances, the first medical instrument caninclude a pocket (or other receptacle or holding device) on the distalend thereof to help secure the object. See, for example, FIGS. 26A and26B.

At block 508, the first medical instrument is moved within the treatmentsite to reposition the object. During movement, aspiration can bemaintained to hold the object to the distal end. Movement can beaccomplished robotically. Movement can be automatic (e.g., following apreprogramed motion or moving to a preprogramed position) or based onphysician input or control. In some instances, the first medicalinstrument is used to move the object to a location within the treatmentsite better suited for lithotripsy. For example, the object can be movedto a location where the fragments can more easily be collected or wherethere is more space in which to work. As another example, the object canbe moved away from sensitive regions of the patient's anatomy. In someembodiments, block 508 can be omitted. That is, in some embodiments, theobject need not be repositioned within the treatment site.

At block 510, lithotripsy is performed on the object with a secondmedical instrument while providing irrigation with the second medicalinstrument. Further, lithotripsy can be performed while the object isheld to the distal end of the first medical instrument medicalinstrument. The fluid flow from the second medical instrument to thefirst medical instrument can serve to hold the object during lithotripsyas well as to direct fragments and dust into the first fluid instrumentfor aspiration and removal. The fluid flow can also maintain a clearvisual field which can assist the physician in performing the procedure.

The method 500 can include one or more additional steps. For example,the method 500 can include providing irrigation through the firstmedical instrument. The first medical instrument may include one or moreadditional fluid channels (in addition to a first fluid channel forproviding aspiration) for providing irrigation. The additional fluidchannels may be arranged, for example, as shown in the device of FIGS.26A and 26B described below. The outflow of irrigation can be orientedaway (e.g., radially away) from the distal end of the first medicalinstrument.

D. Example Systems and Devices for Directed Fluidics.

FIG. 25 is a block diagram illustrating an embodiment of a system 600for employing directed fluidics during a medical procedure, such as anobject removal procedure. In some instances, the methods 300, 400, 500described above can be implemented using the system 600. Additionally,the system 600 may form part of any of the robotic systems describedabove with reference to FIGS. 1-15.

As illustrated, the system 600 includes a first medical instrument 616,a second medical instrument 620, a pump 608 connected to the firstmedical instrument 616, a vacuum 612 connected to the second medicalinstrument 620, and a directed fluidics module or fluidics controlsystem 602 connected to the pump 608 and the vacuum 612. The directedfluidics control system 602 can be configured to control the pump 608and the vacuum 612 to provide directed fluidics (e.g., irrigation andaspiration) to the treatment site through the first and second medicalinstruments 616, 620.

The first medical instrument 616 can be configured to be inserted intothe treatment site via a patient lumen. Alternatively, the first medicalinstrument 616 can be configured to be inserted into the treatment sitepercutaneously. The first medical instrument 616 can be an endoscope(such as a ureteroscope), a catheter (such as a steerable ornon-steerable catheter), a nephroscope, or other type of medicalinstrument as described herein. The first medical instrument 616 caninclude a first fluid channel for providing fluidics (irrigation oraspiration). In the illustrated embodiment, the first medical instrumentis attached to the pump 608 for providing irrigation. The pump 608 isattached to an irrigation source 610, which provides irrigant (e.g., asaline solution) to be pumped through the first medical instrument andinto the treatment site. In some examples, the pump 608 is a peristalticpump. In some embodiments, the pump 608 can be replaced with a vacuumwhich applies a vacuum pressure to draw the irrigant from the irrigationsource 610 and out through the first medical instrument 616.

The first medical instrument 616 can be connected to a first instrumentdevice manipulator 624. The first instrument device manipulator 624 canbe robotically controlled to manipulate the first medical instrument616. For example, the first medical instrument 616 can be articulable orsteerable, and the first instrument device manipulator 624 can be usedto articulate or steer the first medical instrument. Further, the firstmedical device manipulator 624 can be attached to a robotic arm that isconfigured to insert or retract the first medical device 616 into or outof the treatment site. Examples of instrument device manipulators aredescribed above with reference to FIGS. 1-15. The first medical device616 can include one or more working channels through which additionaltools, such as lithotripters, basket retrieval devices, forceps, etc.,can be introduced into the treatment site.

The second medical instrument 620 can be configured to be inserted intothe treatment site via a percutaneous access. Alternatively, the secondmedical instrument 620 can be configured to be inserted into thetreatment site via a patient lumen. The second medical instrument 620can be an endoscope (such as a ureteroscope), a catheter (such as asteerable or non-steerable catheter), a nephroscope, or other type ofmedical instrument as described herein. The second medical instrument620 can include a second fluid channel for providing fluidics(irrigation or aspiration). In the illustrated embodiment, the secondmedical instrument is attached to the vacuum 612 for providingaspiration. The vacuum 612 can be configured to apply a negativepressure to draw fluid out of the treatment site. The vacuum 612 isconnected to a collection container into which withdrawn fluid iscollected. In some examples, the vacuum 612 can be replaced with a pumpwhich pumps liquid from the treatment site, through the second medicalinstrument 620, and into the collection container 614.

The second medical instrument 620 can be connected to a secondinstrument device manipulator 626. The second instrument devicemanipulator 626 can be robotically controlled to manipulate the secondmedical instrument 620. For example, the second medical instrument 620can be articulable or steerable, and the second instrument devicemanipulator 626 can be configured to articulate or steer the secondmedical instrument 620. Further, the second medical device manipulator626 can be attached to a robotic arm that is configured to insert orretract the second medical device 620 into or out of the treatment site.The second medical device 620 can include one or more working channelsthrough which additional tools, such as lithotripters, basket retrievaldevices, forceps, etc., can be introduced into the treatment site.

In some embodiments, fluidics are provided through only one of the firstmedical instrument 616 or the second medical instrument 620, with theinstrument providing both irrigation in aspiration. The instrumentproviding fluidics can be inserted percutaneously into the patient. Insome embodiments, the instrument can be similar to the instrument shownin FIGS. 26A and 26B. The other of the first medical instrument 616 orthe second medical instrument 620 may not provide fluidics and may beused for other functionality, such as breaking up the object to beremoved.

The fluidics control system 602 may include a processor 604 and a memory606. The memory 606 can include instructions that configure theprocessor 604 to determine a characteristic of one of the irrigation andthe aspiration, and control a characteristic of at least one of the pumpor the vacuum based on the determined characteristic. The determinedcharacteristic can be, for example, an instantaneous flow rate of theirrigation or aspiration. The characteristic can be an average flow rateof the irrigation or aspiration over a time interval. The time intervalcan be, for example, 1.0 seconds, 2.5, second, 5 second, 10 second, 15seconds or longer, as well as intervals above and below the listedvalues. The characteristic can be a volume of fluid irrigated oraspirated during a time interval, such as, for example, any of the timeintervals listed above. The characteristic can be an instantaneous fluidpressure associated with the irrigation or aspiration. Thecharacteristic can be an average fluid pressure associated with theirrigation or aspirations over a time interval, such as, for example,any of the time intervals listed above. The fluid pressure can be, forexample, a fluid pressure within the first fluid channel, a fluidpressure within the second fluid channel, or a fluid pressure within thetreatment site itself.

In some instances, the characteristic is determined using one or moresensors, such as the sensors 618, 622 on the first and second medicalinstruments 616, 620, respectively. The sensor 618 can be positioned,for example, in a first fluid channel of the first medical instrument616 or on the first medical instrument 616 itself. The sensor 622 can bepositioned in a second fluid channel of the second medical instrument620 or on the second medical instrument 620 itself. In some embodiments,one or both of the first and second medical instruments 616, 620includes a plurality of sensors 616, 622. The sensors 618, 622 can beflow rate sensors, pressure sensors, or other sensors for determining acharacteristic of the irrigation or aspiration. An output from thesensors 616, 622 can be connected to the processor 604, such that theprocessor 604 can use the output of the sensors 618, 622 to determinethe characteristic. In some instances, the characteristic is determinedfrom the pump 608 or vacuum 612 supplying the irrigation or aspiration.For example, the characteristic can be determined based on a flow rateset by the pump 608 or a vacuum pressure applied by the vacuum 612. Insome instances, the characteristic is calculated from one or more knownor measured parameters. For example, the characteristic can comprisevolume of irrigant within the treatment site calculated based on theamount of irrigant pumped into and/or aspirated from the treatment site.

In some embodiments, the sensors 618, 622 comprise position sensorsconfigured to provide positional information regarding the first andsecond medical instruments 616, 620. The position sensors can provide3-degree of freedom position information (e.g., x, y, and z coordinates)or 6-degree of freedom position information (e.g., x, y, and zcoordinate and pitch, roll, and yaw angles). The position sensors 618,622 can be for example, EM sensors, shape sensing fibers, or other typesof position sensors, including accelerometers, gyroscopes, etc.

In some embodiments, the memory 606 includes instructions that furtherconfigure the processor 604 to calculate a position of a first positionsensor to determine a position of the first medical instrument 616,calculate a position of s second position sensor to determine a positionof the second medical instrument 620, and manipulate the first or secondmedical instruments 616, 620 such that an outflow aperture of the firstmedical instrument 616 oriented towards an inflow aperture of the secondmedical instrument 620.

One or both of the first and second medical instruments 616, 620 can beconfigured to provide both irrigation and aspiration. For example, asillustrated in FIG. 25, the second medical instrument 620 can beconnected to the vacuum 612 for providing aspiration and may also beconnected to the pump 608 (via the dotted line) to provide irrigation.In this embodiment, the second medical instrument 620 can include anadditional fluid channel for providing irrigation. An example of amedical instrument 700 including a first fluid channel for providingaspiration or irrigation and an additional fluid channel for providingthe other of aspiration or irrigation is shown in FIGS. 26A and 26Bbelow.

FIGS. 26A and 26B are perspective and cross-sectional views of a distalend of a medical instrument 700 configured to provide aspiration andirrigation during an object removal procedure. The medical instrument700 can be used as any of the first and/or second medical instrumentsdescribed above. The medical instrument 700 can be inserted into thetreatment site percutaneously or through a patient lumen.

With reference to FIGS. 26A and 26B, the medical device 700 can includean elongate body 702 that terminates at a distal end 704. In theillustrated embodiment, a pocket 706 or recess is formed in a distalface of the distal end. The pocket 706 provides a space into which anobject to be removed can be received during the procedure. In someembodiments, aspiration and/or irrigation holds the object in the pocket706. The object can be held in the pocket 706 during lithotripsy inorder to stabilize and secure the object. As the object is broken apartthrough lithotripsy, the fragments and dust can be aspirated through themedical instrument 700.

The medical instrument 700 can include a fluid channel 708 (see FIG.26B). The fluid channel 708 can terminate at a distal end with a fluidorifice 710. The fluid channel 708 can be used for aspiration orirrigation. In one example, the fluid channel 708 is used foraspiration, and fluid drawn into the fluid channel 708 can be used tohold the object within the pocket 706.

The medical instrument 700 may also include one or more additionalchannels 712 surrounding the fluid channel 708 (see FIG. 26B). Theseadditional channels 712 can be configured to provide the other ofaspiration or irrigation than the fluid channel 708. The additionalchannels 712 may terminate in orifices 714 near the distal end 704 ofthe medical instrument. The orifices 714 can be positioned in the radialsurface of the medical instrument 700 so as to orient flow through theorifices in a radial direction, as shown, for example, in FIGS. 21A and21B. In some embodiments, the medical instrument 700 includes fourorifices 714. In some embodiments, the orifices 714 direct fluid in adirection that is orthogonal or substantially orthogonal to alongitudinal axis of the medical instrument 700. In some embodiments,the orifices 714 direct fluid in a direction that is non-orthogonal orangled with respect to the longitudinal axis of the medical instrument700.

The medical instrument 700 can be articulable. For example, the medicalinstrument can include pull-wires (or other mechanisms) for controllingthe shape or pose of the medical instrument 700.

FIG. 27 illustrates an embodiment of a robotic system 800 arranged forperforming an object removal procedure using directed fluidics. Therobotic system 800 may be similar to the robotic systems described abovewith reference to FIGS. 1-15. In the illustrated embodiment, the roboticsystem includes a plurality of robotic arms 805. The robotic arms 805may be configured to manipulate the instruments and tools used duringthe procedure. As illustrated, the system 800 includes the three roboticarms 805 a, 805 b, 805 c. Other numbers of robotic arms 805 can be usedin other embodiments.

The robotic arms 805 a, 805 b can be attached to a first instrument 801.The first instrument 801 can comprise an outer sheath having a workingchannel and an inner catheter positioned within the outer sheath. Insome embodiments, the robotic arm 805 a controls the outer sheath andthe robotic arm 805 b controls the inner sheath. The first instrument801 can be inserted into the patient through a patient lumen. Asillustrated, the robotic arms 805 a, 805 b can insert the firstinstrument 801 into the patient's lower abdomen through the urethra. Insome embodiments, insertion is performed along a virtual rail asdescribed above. After insertion into the urethra, using controltechniques as described above, the first instrument 801 may be navigatedinto the treatment site (e.g., the bladder, ureters, and/or kidneys) fordiagnostic and/or therapeutic applications.

The robotic arm 805 c can be attached to a second instrument 802. Insome embodiments, the second instrument 802 can comprise an outer sheathhaving a working channel and an inner catheter positioned within theouter sheath. In some embodiments, multiple robotic arms can be used tomanipulate the second instrument 802. In the illustrated embodiment, thesecond instrument 802 is inserted percutaneously (i.e.,laparoscopically) into the treatment site.

With the first and second instruments 801, 802 positioned by the roboticarms 805 as shown in FIG. 27, the system 800 may be configured toimplement directed fluidics as described above. For example, the firstand second instruments 801, 802 can be used to provide irrigation andaspiration to the treatment site as described above.

FIG. 27 provides one example of a robotic system 800 configured fordirected fluidics. Other systems, including other numbers or types ofrobotic arms, other numbers or types of medical instruments, and/orother methods for inserting and controlling the instruments arepossible.

3. Implementing Systems and Terminology.

Implementations disclosed herein provide systems, methods andapparatuses for removing an object from a treatment site of a patient,and in particular to methods and systems that employ directed fluidicsduring an object removal procedure. Directed fluidics can includecontrolling various features of fluid flow (e.g., rate, direction,pressure, etc.) of irrigation and/or aspiration through a treatmentsite, and/or separating an inflow point of irrigation from an outflowpoint of aspiration to facilitate an object removal procedure. In someexamples, directed fluidics involves controlling a flow direction froman inflow point to an outflow point so as to hold or stabilize an objectduring the procedure.

It should be noted that the terms “couple,” “coupling,” “coupled” orother variations of the word couple as used herein may indicate eitheran indirect connection or a direct connection. For example, if a firstcomponent is “coupled” to a second component, the first component may beeither indirectly connected to the second component via anothercomponent or directly connected to the second component.

The phrases and features used herein referencing specificcomputer-implemented processes/functions described herein may be storedas one or more instructions on a processor-readable or computer-readablemedium. The term “computer-readable medium” refers to any availablemedium that can be accessed by a computer or processor. By way ofexample, and not limitation, such a medium may comprise random accessmemory (RAM), read-only memory (ROM), electrically erasable programmableread-only memory (EEPROM), flash memory, compact disc read-only memory(CD-ROM) or other optical disk storage, magnetic disk storage or othermagnetic storage devices, or any other medium that can be used to storedesired program code in the form of instructions or data structures andthat can be accessed by a computer. It should be noted that acomputer-readable medium may be tangible and non-transitory. As usedherein, the term “code” may refer to software, instructions, code ordata that is/are executable by a computing device or processor.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isrequired for proper operation of the method that is being described, theorder and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the claims.

As used herein, the term “plurality” denotes two or more. For example, aplurality of components indicates two or more components. The term“determining” encompasses a wide variety of actions and, therefore,“determining” can include calculating, computing, processing, deriving,investigating, looking up (e.g., looking up in a table, a database oranother data structure), ascertaining and the like. Also, “determining”can include receiving (e.g., receiving information), accessing (e.g.,accessing data in a memory) and the like. Also, “determining” caninclude resolving, selecting, choosing, establishing and the like.

The phrase “based on” does not mean “based only on,” unless expresslyspecified otherwise. In other words, the phrase “based on” describesboth “based only on” and “based at least on.”

The previous description of the disclosed implementations is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these implementations will bereadily apparent to those skilled in the art, and the generic principlesdefined herein may be applied to other implementations without departingfrom the scope of the invention. For example, it will be appreciatedthat one of ordinary skill in the art will be able to employ a numbercorresponding alternative and equivalent structural details, such asequivalent ways of fastening, mounting, coupling, or engaging toolcomponents, equivalent mechanisms for producing particular actuationmotions, and equivalent mechanisms for delivering electrical energy.Thus, the present invention is not intended to be limited to theimplementations shown herein but is to be accorded the widest scopeconsistent with the principles and novel features disclosed herein.

1. A method of administering fluidics during a medical procedure, themethod comprising: inserting a first medical instrument into a treatmentsite, the first medical instrument comprising a first fluid channel anda second fluid channel; providing irrigation into the treatment sitethrough the first fluid channel of the first medical instrument;providing aspiration from the treatment site through the second fluidchannel of the first medical instrument; determining a characteristic ofone of the irrigation and the aspiration; and selecting a characteristicof the other of the irrigation and aspiration based on the determinedcharacteristic.
 2. The method of claim 1, wherein inserting the firstmedical instrument into the treatment site comprises advancing the firstmedical instrument percutaneously into the treatment site.
 3. The methodof claim 1, wherein inserting the first medical instrument into thetreatment site comprises advancing the first medical instrument througha lumen of a patient into the treatment site.
 4. The method of claim 2,further comprising inserting a second medical instrument into thetreatment site through a lumen of the patient.
 5. The method of claim 1,wherein the determined characteristic comprises at least one of aninstantaneous flow rate and an average flow rate over a period of time.6. The method of claim 1, wherein the selected characteristic comprisesat least one of an instantaneous flow rate and an average flow rate overa period of time.
 7. The method of claim 1, wherein the selectedcharacteristic substantially matches the determined characteristic. 8.The method of claim 1, further comprising: determining a characteristicof the treatment site; and when the determined characteristic of thetreatment site exceeds a threshold value, at least one of: reducingirrigation into the treatment site, increasing aspiration from thetreatment site, and providing an alert.
 9. The method of claim 1,wherein the determined characteristic of the treatment site comprisesone of a volume of fluid within the treatment site and an internalpressure of the treatment site.
 10. The method of claim 4, wherein atleast one of the first medical instrument and the second medicalinstrument is robotically controlled.
 11. The method of claim 1, furthercomprising: performing lithotripsy on an object within the treatmentsite to break the object into fragments; and aspirating the fragmentsthrough the second fluid channel of the first medical instrument
 12. Themethod of claim 11, wherein lithotripsy is performed with a secondmedical instrument.
 13. The method of claim 1, further comprising:contacting an articulable distal end of the first medical instrument toan object within the treatment site; and providing aspiration throughthe second fluid channel to hold the object to the articulable distalend.
 14. The method of claim 13, wherein the articulable distal endcomprises a pocket configured to hold the object.
 15. The method ofclaim 14, further comprising performing lithotripsy while the object isheld in the pocket.
 16. The method of claim 13, further comprisingmoving the first medical instrument to reposition the object within thetreatment site.
 17. A system for performing a medical procedure, thesystem comprising: a first medical instrument configured to be insertedinto a treatment site, the first instrument including a first fluidchannel and a second fluid channel; a vacuum connected to one of thefirst fluid channel and the second fluid channel and configured to applya negative pressure to provide aspiration from the treatment site; apump coupled to an irrigation source and the other of the first fluidchannel and the second fluid channel, the pump configured to provideirrigation to the treatment site; and a fluidics control system coupledto the vacuum and the pump, the fluidics control system comprising oneor more processors configured to: determine a characteristic of one ofthe irrigation and the aspiration; and control a characteristic of atleast one of the pump or the vacuum based on the determinedcharacteristic.
 18. The system of claim 17, further comprising a secondmedical instrument that is configured to be inserted percutaneously intothe treatment site.
 19. The system of claim 17, wherein the firstmedical instrument further comprises a flow rate sensor positioned inthe first fluid channel, and wherein an output of the flow rate sensoris connected to the fluidics control system.
 20. The system of claim 17,wherein the first medical instrument further comprises a pressure sensordisposed to measure an internal pressure of the treatment site, anoutput of the pressure sensor connected to the fluidics control system,and wherein the one or more processors are further configured to controlat least one of the pump or the vacuum to adjust at least one of theaspiration and the irrigation based on the measured internal pressure ofthe treatment site. 21-30. (canceled)